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Now viewing: Regulatory Affairs Directors
RC
Reprieve Cardiovascular
Regulatory Affairs Directors
Job Description
Jobs › Milford, MA › Regulatory Affairs Directors Reprieve Cardiovascular Regulatory Affairs Directors Milford, MA Apply The Regulatory Affairs Director will build and lead the global regulatory strategy for our first-in-class heart-failure therapy from clinical development through commercialization. The ideal candidate has deep expertise in FDA and EU medical device regulations and will lead interactions with regulatory authorities to ensure global compliance and product success.
Responsibilities include:
- Develop and execute regulatory strategies for U.S. and EU markets, including PMA, IDE, 510k, and CE Mark submissions.
- Manage all aspects of regulatory submissions and discussions including supplements, 5-day notices, Q-sub meetings, notified-body structured dialog interactions, etc.
- Prepare and submit regulatory documentation for breakthrough device designation, original PMA, and EU MDR conformity assessment.
- Serve as the primary liaison with regulatory agencies including the FDA, Notified Bodies, and other international regulators.
- Establish and implement regulatory procedures and SOPs aligned with global requirements and ensure continued compliance with applicable regulations and standards (21 CFR Part 820, ISO 13485, EU MDR, etc.).
- Build and mentor a regulatory team to support submissions, labeling, and compliance activities.
- Oversee the creation, review, and maintenance of regulatory documentation including Design Dossiers, Technical Files, and risk management files.
- Partner with R D, Quality Assurance, Clinical, Manufacturing, and Marketing to ensure regulatory considerations are incorporated throughout the product lifecycle.
- Co-own, along with Quality, the
ISO 13485
quality-management system, risk management (ISO 14971), design-change control and CAPA closure metrics and represent the company regulatory function in audits, inspections, and regulatory meetings.- Drive global market expansion beyond US/EU, including Canada, Australia, Japan, China and maintenance of MDSAP audit readiness.