BioTalent is partnered with a fast-growing device manufacturer as they dive into the IVD market to find a strong Regulatory Affairs Manager to join their ranks. You will get to drive regulatory changes throughout new and existing product lines to align with both FDA and EU regulations while showcasing your leadership skills to upper management.

Key Responsibilities:

• Develop and implement regulatory strategies to facilitate timely approvals for new and existing products.
• Manage global product registrations, licensing, and regulatory compliance across key markets.
• Serve as the primary liaison with regulatory bodies, including the FDA, Notified Bodies, and international agencies.
• Oversee the preparation and submission of regulatory documentation to ensure compliance with global standards.
• Support regulatory compliance throughout the product lifecycle, including post-market surveillance activities.
• Lead efforts to transition products from IVDD to IVDR compliance.
• Collaborate with quality assurance teams to align regulatory and quality system requirements.
• Guide and support the expansion of the Regulatory Affairs function, including hiring, training, and mentoring team members.
• Manage external consultants, contractors, and regulatory support resources.
• Foster a culture of compliance, quality, and continuous improvement across the organization.

Qualifications & Experience:

• Minimum of 10 years of experience in regulatory affairs, particularly with Class I and Class II (IVDD/IVDR Class A/B/C) medical devices.
• Strong knowledge of international regulatory frameworks, including MDSAP, EU IVD regulations, and global quality system standards.
• Demonstrated expertise in preparing technical files and documentation for IVDR compliance.
• Experience with global product registration processes across markets such as the US, Canada, Brazil, Japan, EU, Australia, and APAC.
• Exceptional organizational, communication, and leadership skills.

Benefits for the Regulatory Affairs Manager

• Hybrid work structure (3 days onsite, 2 from home).
• Second-to-none health benefits.
• Education assistance for continued learning.
• New facility with an incredible culture.