Regional Program Management Executive
Location
Singapore
Posted
53 days ago
Salary
0
Seniority
Mid Level
No structured requirement data.
Job Description
Regional Program Management Executive
Flintex Consulting Pte Ltd
Job Description • Monitor compliance to national and international quality standards and related regulations. • Participate in quality related activities such as audit, qualification program, claims etc. • Any other ad-hoc duties as assigned by the Management/Manager from time to time. • Act as a representative for operations to Internal and External Stakeholders • Manage stakeholder expectations and ensure timely completion of project deadlines. • Create and write Standard Operations Procedures • Create Process flowcharts. • Conduct Internal and External Training with operational staff. • Coordinate with IT team for enhancement systems integration • Manage testing for IT projects. • Support on daily operational issues. • Maintain SOP internally at a regional level. • Supporting Daily/Weekly/Monthly/KPI reports for customer. • Attend to customer request on timely matter. • Act as a Control Tower for communication between internal and external customer. • Aligning processes with internal and external operation. • Work with Operation Manager to make improvement for operation. • Conduct training for internal operation if there are new requirement from customer. • Maintain good relationship with customer. • Support adhoc quotation if required. • Travel overseas if required. • Any other ad-hoc duties as assigned by the Management/Manager from time to time. Job Requirements • Min Diploma in Logistics/Supply Chain/Transportation/International Business and 2 years working experience in Freight Forwarding/Logistics Industry, Air/Ocean freight experience is a plus. • Good command of written and spoken English, proficiency in other languages is a bonus as to liaise with other regional offices. • Proficient in MS Office and Teams. • Experience in at least one aspect of freight forwarding operations either Export or Import, with both experiences will be added advantage. • Detail oriented and good time management. • A good team player. • Responsible and able to work remotely to deliver key task completed on time. Working hours: Mon to Fri 8.30am - 6pm
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Role Description The primary job responsibility for this position is overseeing the day-to-day functions of the Dentsply Sirona Essential Dental Solutions team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits 510ks for the products and manages communications with FDA including pre-subs. The individual will also be responsible for mentoring and providing guidance to their direct reports and cross-functional product development teams on US and EU regulatory requirements. This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance. Key Responsibilities - Develops and implements regulatory strategies to obtain and maintain regulatory approvals for medical devices and other regulated products globally. - Leads and manages regulatory submissions, including 510(k) submissions, and technical files for CE marking. - Manages communications with FDA and EU notified bodies on behalf of the company for FDA pre submissions, FDA 510(k) submissions and EU technical files submissions. - Provides regulatory guidance and support to cross-functional teams throughout the product lifecycle. - Reviews and interprets regulatory requirements and guidance documents to ensure compliance. - Coordinates regulatory activities with internal teams and external regulatory agencies. - Reviews and approves product labelling and claims for the US and EU markets. - Stays current with regulatory requirements and updates affected policies and procedures. - Fosters professional interactions with internal and external stakeholders through various communication channels, enhancing business relationships. - Manages day to day activities for less senior Regulatory Affairs professionals, including but not limited to mentoring, coaching, performance reviews, developmental plans, succession planning. - Complies with company and departmental policies and administrative requirements. - Performs other duties as assigned or as needed. Qualifications - Bachelor's degree in a relevant field, such as life sciences, regulatory affairs, or a related discipline. - Regulatory Certification (such as RAC from the Regulatory Affairs Professionals Society) or Master’s degree in a scientific discipline is a plus. Requirements - 5(+) years of experience in regulatory affairs, preferably in the medical device industry. - Experience with leading regulatory submissions and managing regulatory projects. - In-depth knowledge of FDA 510(k) and international regulations (e.g., EN ISO 13485, EU MDR). - Experience with software as a medical device, AI and/or medical devices containing software is a plus. - Proficiency with Microsoft Office Suite. - Proficiency with Regulatory software. Key Required Skills, Knowledge, and Capabilities - Strong leadership, project management, and organizational skills including attention to detail. - Strong written and verbal communication skills. - Prior technical writing experience and proven track record with FDA and EU regulatory submissions. - Excellent interpersonal skills. - Ability to work effectively in a team environment and independently. - 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. - Leadership experience within medical device organizations. Key Leadership Behaviors - Actively articulates and promotes Dentsply Sirona’s vision and direction. - Advocates on behalf of the customer. - Values driven with an insistence on excellence. - Promotes high performance, innovation, and continual improvement. - Consistently meets Company standards, ethics, and compliance requirements. - Strong results orientation and analytical skills. - Clear and effective communication with key stakeholders, which span across multiple levels, socio-geographic areas, and functional expertise. - Resolves conflicts and fosters a positive working environment. Benefits - This position can be a remote working arrangement. Candidates must be located in the US, ideally in the eastern time zone. Company Description 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.
Strategy Program Manager
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Manager/Senior Manager, Financial Partnerships, APAC (Local Payment Providers)
AirwallexEmpowering businesses to grow beyond borders
About Airwallex Airwallex is the only unified payments and financial platform for global businesses. Powered by our unique combination of proprietary infrastructure and software, we empower over 200,000 businesses worldwide - including Brex, Rippling, Navan, Qantas, SHEIN and many more - with fully integrated solutions to manage everything from business accounts, payments, spend management and treasury, to embedded finance at a global scale. Proudly founded in Melbourne, we have a team of over 2,000 of the brightest and most innovative people in tech across 26 offices around the globe. Valued at US$8 billion and backed by world-leading investors including T. Rowe Price, Visa, Mastercard, Robinhood Ventures, Sequoia, Salesforce Ventures, DST Global, and Lone Pine Capital, Airwallex is leading the charge in building the global payments and financial platform of the future. If you're ready to do the most ambitious work of your career, join us. 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Transformation Program Manager
CalixTo enable broadband service providers of all sizes to simplify, innovate and grow.
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