Biotech Partners
Director, Regulatory Affairs
The Director, Regulatory Affairs will lead the strategic and operational regulatory activities supporting a portfolio of in vitro diagnostics (IVDs), laboratory instruments, and reagents. This individual will serve as the principal regulatory authority within the organization, ensuring compliance with global regulatory requirements while enabling timely product development, approval, and commercialization.
The role requires strong leadership, cross-functional collaboration, and in-depth knowledge of regulatory frameworks including FDA, EU IVDR, Health Canada, and other international markets.
Key Responsibilities
Regulatory Strategy & Leadership
Develop and implement global regulatory strategies to support product lifecycle (design, development, registration, post‑market).
Provide regulatory guidance to R&D, Clinical, Marketing, and Quality teams to ensure alignment with business goals and compliance.
Lead regulatory intelligence efforts to monitor emerging trends and regulatory changes.
Regulatory Submissions & Approvals
Oversee the preparation, review, and submission of high‑quality regulatory filings (e.g., 510(k), PMA, Technical Files, Health Canada Class II/III applications).
Serve as the liaison with regulatory authorities (FDA, Notified Bodies, etc.), managing communications and responses to inquiries or deficiency letters.
Compliance & Risk Management
Ensure compliance with applicable regulatory standards including FDA QSR, ISO 13485, IVDR, and other national/international regulations.
Maintain regulatory documentation and support internal/external audits and inspections.
Lead regulatory input into risk management and product change processes.
Team Management
Lead, coach, and mentor a team of regulatory professionals.
Promote a culture of continuous improvement and professional development.
Qualifications
Bachelor’s degree in a life science, engineering, or related field (Master’s or PhD preferred).
Minimum of 10 years of regulatory affairs experience in the IVD or medical device industry, with at least 5 years in a leadership role.
Demonstrated experience with U.S. FDA and international regulatory submissions and approvals.
Strong working knowledge of regulatory standards (21 CFR Part 820, ISO 13485, IVDR).
Excellent project management, communication, and leadership skills.
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The role requires strong leadership, cross-functional collaboration, and in-depth knowledge of regulatory frameworks including FDA, EU IVDR, Health Canada, and other international markets.
Key Responsibilities
Regulatory Strategy & Leadership
Develop and implement global regulatory strategies to support product lifecycle (design, development, registration, post‑market).
Provide regulatory guidance to R&D, Clinical, Marketing, and Quality teams to ensure alignment with business goals and compliance.
Lead regulatory intelligence efforts to monitor emerging trends and regulatory changes.
Regulatory Submissions & Approvals
Oversee the preparation, review, and submission of high‑quality regulatory filings (e.g., 510(k), PMA, Technical Files, Health Canada Class II/III applications).
Serve as the liaison with regulatory authorities (FDA, Notified Bodies, etc.), managing communications and responses to inquiries or deficiency letters.
Compliance & Risk Management
Ensure compliance with applicable regulatory standards including FDA QSR, ISO 13485, IVDR, and other national/international regulations.
Maintain regulatory documentation and support internal/external audits and inspections.
Lead regulatory input into risk management and product change processes.
Team Management
Lead, coach, and mentor a team of regulatory professionals.
Promote a culture of continuous improvement and professional development.
Qualifications
Bachelor’s degree in a life science, engineering, or related field (Master’s or PhD preferred).
Minimum of 10 years of regulatory affairs experience in the IVD or medical device industry, with at least 5 years in a leadership role.
Demonstrated experience with U.S. FDA and international regulatory submissions and approvals.
Strong working knowledge of regulatory standards (21 CFR Part 820, ISO 13485, IVDR).
Excellent project management, communication, and leadership skills.
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