Regulatory Affairs Manager

QUALIFICATIONS:

- BS or MS in a scientific discipline with 7-10 years of direct experience in Quality Assurance and Regulatory Affairs within the Medical Device industry

- Strong knowledge of FDA and global regulatory requirements (EU/UK Regulations, ICH Guidelines, Common Rule, 21 CFR 56, 45 CFR 46; ISO 13485, 21 CFR 820, 21 CFR Part 10, 21 CFR Part 11; GMP, GLP, GCP, CMC, Compliance, FDAC Act, IND, CTD, NDA, PDUFA)

- Proficiency in GMP and GCP regulations with a clear understanding of Medical Device product requirements

- Ability to find creative solutions to issues impacting timelines and budgets

- Experience with CAPAs and internal audit systems

- Detail-oriented, well-organized, and deadline-driven

- Excellent verbal and written communication skills

- Strong interpersonal skills and the ability to interact with staff at all levels

- Exceptional organizational and problem-solving abilities

- Ability to thrive in a fast-paced environment and maintain a positive attitude under pressure

- Capable of working independently with minimal supervision

- QA/RA: 7 years (Required)

- Location: Watertown, MA 02472 (Required)

RESPONSIBILITIES

- Report to the VP of Quality Assurance and Regulatory Affairs

- Collaborate with the company’s cross-functional team to ensure the new product line meets technical, clinical, and market standards

- Create and manage a product/project database to document the history of the DermaTemp (DT) medical device product release and ongoing maintenance

- Develop release plans for the product line, including key milestones and timelines

- Work with the Regulatory lead and Quality team to draft meeting requests and supporting briefing packages for engagements with the cross-functional team

- Coordinate with cross-functional departments to prepare documentation necessary for submitting applications (MDD to MDR) to the EU Notify Body

- Support the VP of QA/RA in driving the clinical portion of the product line: collaborate with the external study team to develop patient recruitment strategies, operational feasibility, and implementation of study objectives

- Manage study documents such as consent forms, study manuals, and subject recruitment materials

- Maintain up-to-date knowledge of the data, information, and formats required for inclusion in regulatory applications

- Review data from contributing departments and provide feedback to ensure accurate and complete documents for regulatory standards (UDI, IFU, Labeling, Packaging, Marketing)

- Serve as a key member of the matrix regulatory team, including generating meeting agendas and minutes

- Contribute to the generation and review of regulatory strategy documents

- Independently manage interactions with clinical monitors, data management, safety, regulatory, and QA team members, both internally and externally, to support product release

- Work with departmental leadership to maintain and continuously improve EN ISO 9001, ISO 13485, EN ISO 60601, and other standards

- Participate in the Corrective Action and Preventive Action (CAPA) Review Board, internal and external audits, and training programs

- Recommend corrective actions necessary to ensure conformity with quality specifications

- Participate in cross-functional sub-teams focused on executing regulatory strategy

- Contribute to the improvement and development of department policies, procedures (RA SOPs), and best practices in line with the growing number of submissions and approvals worldwide

- Assist in managing the regulatory information management system (RIMS) and support the Quality function with implementing a new eQMS and updating current QMSR processes