Regulatory Affairs Manager
3 weeks ago
Associate Director (Regulatory Affairs)
My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory Affairs.
Associate Director (Regulatory Affairs)
Type: Full-time
Lead and oversee regulatory affairs activities related to Medical Device Regulation (MDR) compliance.
Guide the company through the MDR transition process for Medical Device Class IIa or above products.
Manage a team of regulatory affairs professionals, providing mentorship and leadership.
Ensure timely submissions and approvals for regulatory filings and compliance documentation.
Collaborate cross-functionally with R&D, Quality Assurance, and Clinical teams to support product development and regulatory strategies.
Stay updated on regulatory changes and requirements to ensure company compliance.
Bachelor's degree in a related scientific or technical field; Minimum 8 years of experience in regulatory affairs within the medical technology industry.
Proven success in leading Medical Device Class IIa or above products through the MDR process.
Strong knowledge of European regulatory requirements and standards (MDR, ISO 13485, etc.).
Experience managing a regulatory affairs team is desirable.
Strategic thinker with the ability to influence decision-making at the executive level.
Competitive salary and benefits package.
Direct involvement in shaping the regulatory strategy of a growing medical technology company.
Reporting directly to the co-owners of the business, providing significant status and influence within the organization.
If you are a proactive and driven regulatory affairs professional looking for an exciting opportunity to lead MDR compliance efforts and contribute to the growth of a cutting-edge medical technology company, we encourage you to apply.
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