• Developing and leading global regulatory strategies to support business objectives • Leading and assisting with submissions and correspondence with global regulatory authorities, including 510(k), PMA, De Novo authorizations, IDE, MDR CE marking, UKCA marking, etc. • Establishing processes for efficiently addressing the requirements of multiple regulatory frameworks at scale • Developing and executing premarket and postmarket regulatory project plans and strategies, including assessments of change controls • Working closely with cross-departmental subject matter experts to guide the creation of documentation needed for regulatory applications and internal records • Work closely with business leadership to ensure regulatory strategy aligns with commercial goals • Making regular reports to our executive team, operationalizing leadership direction quickly and efficiently

• Serve as a technical leader and subject matter expert focused on SOC 2 readiness and examination audits. • Ensure client satisfaction and efficient execution of engagement plans. • Coach and advise team members in executing SOC 2 compliance tasks. • Build client relationships grounded in understanding their operations and compliance needs. • Deliver top-notch services in business, IT, and security risk management.

• Build collaborative relationships and serve as a trusted advisor to divisional leadership, laboratory operations, phlebotomy, and sales/commercial personnel at all levels • Provide proactive compliance guidance and support on a broad range of clinical laboratory arrangements with hospitals/health systems, physicians, medical clinics, and other clients • Lead compliance-related due diligence and integration activities for health system and regional laboratory acquisitions within the division • Engage with other departments, including Human Resources, Marketing, Finance, Information Technology, Revenue Cycle Management, Real Estate, Law/Contracts, Science and Technology, and Quality to advance cross-functional initiatives and projects in support of Labcorp Diagnostics compliance and business objectives • Conduct thorough internal investigations into potential compliance program violations and other allegations of misconduct • Implement compliance training programs and educational opportunities for new and existing employees to ensure a thorough understanding of relevant laws, regulations, and Labcorp policies and procedures • Support compliance audit activities within the division to identify gaps and areas for improvement

Role Description As our company continues to grow we are seeking a Regulatory and Start Up Specialist to join our growing team. - Responsible for delivery, in terms of timeliness and quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks. - Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities, Ethics Committees, and other applicable local bodies according to local requirements and within required timelines to obtain all necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP. - Interaction with CA/EC for study purposes and handling responses to the CA/EC. - Providing regular updates about CA and EC submissions to the Start Up Lead and/or Regulatory Lead assigned to the study and to Project Manager/Project Team. - Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership. - Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria. - Partner with the assigned site CRA to ensure alignment in communication and secure site review and manage collection of essential documents required for site activation/IMP release. - Customize country/site specific Patient Information Sheet and Informed Consent Form. - Responsible for/facilitates the translation and co-ordination of translations for documents. - Maintain communication with other key functions participating to country start up e.g., Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts management group on project specific status and deliverables. - Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country. - When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department. - May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study. - Keep an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge within PFM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations. - Maintain audit/inspection readiness at all times and file documents as per TMF plan and/or study specific plans in the relevant TMF. - May support the clinical team performing Pre-Study Site Visits. Qualifications - Bachelor’s degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience. - A qualification in Pharmacy/ work experience as a Pharmacist would be highly beneficial. - 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies. Requirements - Strong communication and organizational skills. - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required. - Fluency in English. Benefits - We strive to ensure employees feel appreciated for the contributions they make every single day. - You will provide input and have your ideas valued and nurtured, impacting positive change for the company. Company Description Precision for Medicine is a Clinical Research Organization. Precision’s uniquely integrated offering enables the science of precision medicine by combining novel clinical trial designs, industry-leading operational and medical experts, advanced biomarker and data analytics solutions, and an unequivocal real passion for rare diseases and oncology, in addition to working across other therapeutic areas.