Regulatory Affairs Manager
Our client is a recognized leader in the area of respiratory medicine. As they strive for continued improvement and their future growth, they are always seeking top talent to join their team.
They are currently looking for an experienced, passionate & dynamic Regulatory Affairs Manager to have a hands-on role in leading regulatory strategies for new products, lifecycle management & manufacturing improvements.
- Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs. Support international registrations.
- Manages the preparation of registration and negotiates submission data requirements with regulatory authorities and internal technical teams.
- Evaluates manufacturing changes for regulatory impact and to ensure compliance with applicable regulations.
- Deploy, maintain, and execute a worldclass medical device Regulatory Affairs system.
- Oversee generation, revision, and review of Regulatory Affairs documents consistent with the evolving interpretations of current regulatory submission standards and guidance.
- Develop and maintain relationships with regulatory peers, QA support and other business and strategic partners.
- Perform and support due diligence activities in support of our clients’ business strategy deployment.
- Provide expertise and guidance in interpreting US, EU, and foreign governmental regulations, agency guidelines, and internal/corporate policies to ensure compliance is maintained and results are achieved.
- Several years related experience in the medical device, pharmaceutical, and/or medical diagnostics industry, with at least 5 years of experience in Regulatory Affairs.
- Demonstrated product design, manufacturing, and supply chain process expertise.
- Sound judgment and decision making capabilities in technical, business, and regulatory compliance arenas, with strong expertise of domestic and international regulatory compliance requirements
- Demonstrated ability to work constructively across all functions of the organization
- International work experience.
- Direct experience with successful submissions – e.g., US 510K and EU MDD / MDR.
Please apply with your CV or contact Kasia Krasuska for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.
+49 30 16 63 83 76