Senior Regulatory Affairs Specialist Location: Sarasota, FL; Charlotte, NC; Milford, DE; or York, PA, United States Job Description: Company: Dentsply Sirona, Inc Dentsply Sirona is the world's largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona's products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina. The company's shares are listed in the United States on NASDAQ under the symbol XRAY. Bringing out the best in people As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we're looking for the best to join us. Working at Dentsply Sirona you are able to: Develop faster - with our commitment to the best professional development. Perform better - as part of a high-performance, empowering culture. Shape an industry - with a market leader that continues to drive innovation. Make a difference -by helping improve oral health worldwide. This position can be a hybrid working arrangement for someone that is near one of the following Dentsply Sirona locations: Sarasota, FL; Charlotte, NC; Milford, DE; or York, PA. Job Summary: The Senior Regulatory Specialist is a contributing member of cross-functional teams in support of regulatory market access activities for US, Canada, EU, and other countries. May support NPD and Sustaining activities for the US, Canada and EU markets. Also supports additional international registrations. Key Responsibilities: - Assists in development and execution of regulatory strategies to obtain and maintain regulatory approvals for medical devices - Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissions and technical files for CE Marking - Maintains regulatory files and databases to ensure compliance with regulatory requirements - Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle - Participates in review of labelling and claims for the US and EU markets. - Reviews and interprets regulatory requirements and guidance documents to ensure compliance - Coordinates regulatory activities with internal teams and external regulatory agencies - Supports regulatory audits and inspections as SME for questions related to market access - Stays current with regulatory requirements and updates affecting medical devices - Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships - Complies with company and departmental policies and administrative requirements - Performs other duties as assigned or as needed Education: - Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline Years and Type of Experience: - 5(+) years of experience in regulatory affairs, preferably in the medical device industry - Experience with leading regulatory submissions and documentation, including 510(k) submissions and CE marking - In-depth knowledge of FDA regulations and international standards (e.g., ISO 13485, MDSAP, EU MDR) Required Computer / Software Skills: - Proficiency with Microsoft Office Suite - Proficiency with Regulatory software Key Required Skills, Knowledge, and Capabilities: - Strong attention to detail and organizational skills - Excellent communication (both written and verbal) and interpersonal skills - Ability to work effectively in a team environment - Knowledge of regulatory affairs principles and practices - Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported - Willingness to learn and adapt to new processes and technologies - Regulatory registration experience within med device organizations - Prior technical writing experience and proven track record with FDA and EU regulatory submissions preferred. Dentsply Sirona is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, disability, or protected Veteran status. We appreciate your interest in Dentsply Sirona. For California Residents: We may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).

Role Description This is a working account manager role where the account manager is required to work alongside the rest of the team. This is not solely a management role. The Account Manager will work closely with the Director of Global Trade Services & VP of Global Trade Services to deliver client-related solutions and services specified within the scope of the client’s SOW. Serve as an extension of our client’s team or organization and ensure compliance per our client’s established policies, procedures and risk tolerance, while adhering to Vigilant’s core values. Ensure the team’s highest level of quality while maximizing bottom-line profit. Primary Job Responsibilities - Serve as the client’s primary point of contact for all communications and account activities. - Classification of client products with their respective Worldwide ECCN & HTS/HS classifications as defined by the SOW. - Research and identify possible PGA and FTA requirements for the client products. - Responsible for the daily management and delivery of all solutions and services specified within the scope of a Managed Services Program and adherence to service level agreements (SLAs). - Responsible for communicating the request to perform any support request outside the scope of a Managed Services Program or Project to the Director of Global Trade Services &/or VP of Client Success. - Ensure tracking of all relevant Key Performance Indicators (KPIs). - Provide weekly and monthly operational updates as specified by Director of Global Trade Services & VP of Client Success. - Responsible for coordinating, preparing and delivering Quarterly Business Reviews as specified by Director of Global Trade Services & VP of Client Success. - Perform and ensure the highest level of quality in the delivery of services to the client through Weekly, Monthly and Quarterly audits of the team’s work. - Other duties as assigned or required by the client specific SOW. Other Representative Job Duties - Manage overall change control processes, perform audits and quality assurance as specified by VP of Global Trade Services to ensure client and employee satisfaction. - Ensure work product is at the highest level of accuracy and timeliness. - Proactively follow-up with clients to monitor effectiveness of team performance. - Participate in scheduling, recruiting, mentoring, training, hiring and firing of team members. - Responsible for the accurate and timely submission of daily hours for all team members. - Responsible for learning and leveraging technology in the delivery of all solutions and services specified within the scope of the Project/Program. - Responsible for monitoring and responding to client and Vigilant emails in a timely manner. - Responsible for answering and responding to client and Vigilant cell phone calls in a timely manner. - Ensure the optimal and efficient allocation of resources to maximize profitability while ensuring client satisfaction. - Develop and implement personal and team Back-Up/Disaster Recovery plans. - Oversee cross-training of team to increase compliance skills. - Responsible for assisting on other client projects (bandwidth permitting) and providing back-up for other client accounts. - Review/audit import and export transactions to ensure accuracy and compliance with the various regulations. - Responsible for executing Export and Import controls as directed by the Client’s Policies, Processes and Procedures. - Identify on a timely basis all account challenges, while providing strategies and approaches to overcome these barriers/challenges. - Ensure the timely and accurate completion of projects, within budget. - Proactively analyze client/account data to identify opportunities for operational improvements. - Develop and implement new processes and procedures to improve operational efficiency. - Identify opportunities to offer additional solutions to client based on need or value. - Identify opportunities to offer new services, solutions or technology to Vigilant clients. Qualifications - Bachelor’s Degree required, preferably in Business or other related field. - Minimum 7 years’ experience in a corporate trade compliance, customs broker or compliance consulting environment. - Advanced knowledge of import and export trade compliance processes, policies and controls. - Excellent analytical and organizational skills with the ability to perform the day-to-day account activities independently with minimal supervision. - Demonstrated ability to organize and prioritize work in a dynamic and complex environment to meet deadlines and daily requirements. - Demonstrated ability to work cross-functionally with Legal, Sales, Operations, Logistics, Engineering, Finance and IT executives to achieve clients’ business and compliance objectives. - Demonstrated ability to communicate (verbally and written) effectively with clients, coworkers, and leadership. - Demonstrated leadership skills such as conflict/issue resolution, strong client interfacing skills. - Demonstrated professional knowledge of Microsoft Office (Word, Excel, Power Point). - Customs Brokers License preferred, professional certificates, licenses, and training experience a plus. Benefits - Company offers health insurance with Health Savings Account (HSA) & Flexible Spending Account (FSA). - Vision, dental & supplemental insurance plans. - Company paid STD, LTD, Life Insurance/AD&D. - Employee Assistance Program (EAP) and Employee Perks Program. - 401K plan with company match.

Job Overview: Perform various project management and regulatory affairs activities for Fortrea clients. Manage team including performance reviews, human resource issues, and assist Senior Management in assigning resources to projects as required. Manage, coordinate and oversee the overall Regulatory Operations associated with creation/revision/compilation/approval of specifications, regulatory and labeling documents across the product lifecycle for submission by Fortrea clients to US, EU, Japan, and ROW health authorities within the agreed/stated timelines, as applicable. The post holder is responsible for supporting team members in providing this service to clients either as a support function to the client project groups or as stand-alone business. Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner. Summary of Responsibilities: - Review and approval of documents, reviewing investigations and providing inputs based on scientific understanding and compliance acumen, in the Electronic Platform(E.g COMET) - Investigating Non-Conformances/OOS/OOE/OOT. - Writing Scientific and Compliant Investigations. - Prepare Weekly Quality Dashboards/Quality Improvement plans(Statistics/Graphs/PPTs).Execution of Q&C Dashboard - Support Audits/Internal Check Round - Co-ordinate /Facilitate Training process through Summit Platform - Implement, maintain and support Daily activity of Laboratory Processes (e.g Training Management, Reference Standard Management etc.) - Perform Gap assessment of SOP /Preparation/Revision of SOPs in Electronic Platform( TruVAult) - Scope may evolve based on QA/business needs - Identify potential issues, perform trouble shooting, resolve conflicts and provide solutions as applicable. Qualifications (Minimum Required): - Bachelor’s in pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or Masters) with experience of 7-9 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR - Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream with at least 79 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 7-9 years of experience will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” - Bachelor or Master degree, scientific oriented (pharmaceutical, chemical or biological sciences) or equivalent by experience with at least 10-15 years’ experience in pharmaceutical industry preferably in the Quality assurance department - Speaking-English and/or other languages as applicable. Experience (Minimum Required): - At least 1+ year experience in project management and people management is desirable. - Industry experience of which 7-9 years of experience in the job discipline (e.g. Regulatory Affairs / Quality Assurance / Analytical science / Packaging, polymer and/or printing stream / Formulation science / Material Management and overall Drug Development and Manufacturing Process. - Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools. - Good understanding of the pharmaceutical product life cycle and regulatory requirements, GxP and ICH-GCP guidelines desirable. - Good organizational and time management ability. - Good analytical capabilities and Customer focus. - Good verbal, written and presentation skills. - Leadership capabilities. - High degree of accuracy with attention to detail. - Ensure client and global regulatory compliance. - Anticipate/identify problems and takes appropriate action to correct. - Capabilities to face internal and external Audit situation. - Proactive and take initiative - Open for change and improvement - Ability to meet deadlines - Detail-oriented with commitment to high level of data integrity and accuracy - Able to work independently - Good team player, excellent verbal and written communication skills with leadership qualities - Accuracy and commitment to timeframes - Able and willing to work in a global environment - Able to communicate effectively - Quality mindset Preferred Qualifications Include: - Bachelor’s in pharmacy or related science degree (or equivalent); advanced degree (e.g., PhD or Masters) with experience of 7-9 years. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” OR - Bachelor’s degree from Engineering /B.Tech /Packaging /Polymer /Printing stream with at least 79 years of experience in Packaging field or Packaging Postgraduate/Diploma/Certification in Packaging with minimum 7-9 years of experience will be preferred. “Fortrea may consider relevant and equivalent experience in lieu of educational requirements.” - Knowledge of data management system, pharmaceutical product life cycle and Management Information System (MIS) will be preferred. - Knowledge of data management system and pharmaceutical product life cycle will be preferred. - 1+ year experience in project management and people management is desirable. - Diploma or certification in Regulatory Affairs will be preferred. Physical Demands/Work Environment: - Physical demands: Available for regional or global travel 5-10% of the time including overnight stays as necessary consistent with project needs and office location. - Work environment: Office environment or remote. Learn more about our EEO & Accommodations request here.

Role Description Au sein de l’unité Prélèvements d'Eau et Contrôles (4 agents encadrés), vous assurez le pilotage et la mise en oeuvre des politiques publiques relatives à la gestion quantitative de la ressource en eau et aux contrôles dans le domaine de l'environnemental dans le département de l'Isère. - Animation et management de l'unité : - Organiser et coordonner l'activité de l'unité : planification du travail, animation des réunions, encadrement et accompagnement des agents. - Contribuer au fonctionnement du service environnement (réunions interservices, représentation interne et externe). - Participer aux instances partenariales, notamment la MISEN et ses déclinaisons stratégiques. - Pilotage de la gestion de crise sécheresse : - Coordonner la préparation et la gestion des épisodes de sécheresse à l'échelle départementale et interdépartementale (Bièvre-Liers-Valloire). - Animer les comités de l'eau, assurer le suivi des ressources, coordonner les contrôles et proposer les mesures de restriction. - Contribuer à l'élaboration et à la mise en oeuvre d'un arrêté cadre sécheresse inter-départements, sur l'ensemble de l'axe Isère. - Gestion structurelle de la ressource en eau : - Piloter le suivi des études et dispositifs de gestion quantitative (volumes prélevables, PTGE, ressources stratégiques) sur les bassins versants. - Participer aux travaux des partenaires institutionnels, notamment l'EPTB Isère, et contribuer aux réflexions stratégiques (SDAGE, plan eau, adaptation au changement climatique). - Pilotage de l'instruction des dossiers "loi sur l'eau" - prélèvements : - Superviser l'instruction des dossiers liés aux prélèvements en eau (forages, captages, prélèvements superficiels et souterrains). - Assurer le suivi des autorisations uniques de prélèvement pour l'irrigation et des plans annuels de répartition, en lien étroit avec les acteurs agricoles. - Accompagner les collectivités pour la mise en conformité des captages d'eau potable et instruire les demandes liées aux usages spécifiques (neige de culture, industrie). - Apporter votre expertise dans les procédures ICPE et d'urbanisme. - Pilotage des contrôles environnementaux : - Définir et mettre en oeuvre la stratégie départementale de contrôle, en coordination avec les services concernés. - Suivre les suites administratives et judiciaires (contentieux, mise en demeure, lien avec les parquets). - Participer aux instances dédiées (COLDEN). - Assurer le pilotage des contrôles liés à la conditionnalité environnementale de la PAC. - Être le référent pour le service de l’environnement auprès de la MISA. Qualifications - Connaissances techniques et réglementaires dans le domaine de l'eau et des milieux aquatiques. - Capacités d'analyse, de synthèse, de rédaction de documents administratifs (courriers, décisions, arrêtés préfectoraux). - Capacités à manager une équipe de travail. - Aisance à l'oral. Requirements - Les compétences pourront notamment s'acquérir via les formations dispensées par le CVRH. Éléments de candidature - Documents à transmettre : Envoi du CV et d'une lettre de motivation est obligatoire. - Personnes à contacter : - helene.marquis@isere.gouv.fr - pierre-henri.peyret@isere.gouv.fr