Regulatory Affairs Director
4 weeks ago
AbbVie is seeking a highly skilled Regulatory Affairs Director to support the company's Body Contouring devices for marketed products. The successful candidate will be responsible for coordinating and managing global submissions to support renewals, registrations, and new submissions.
Key Responsibilities
Directs and supports the development of the regulatory strategy related to MPS activities for device regulatory activities in various countries, including the US, EU, Japan, and China.
Supports regulatory intelligence and policy activities, monitoring regulatory pathways, legislation updates, policies, and initiatives that could impact marketed products.
Collaborates with regulatory agencies and Notified Bodies, providing leadership and expertise in regulatory operations, change control, lifecycle management, and technical file/design dossier management.
Develops and implements regulatory policies, intelligence interpretation, and strategy for medical devices to support global regulatory plans, due diligence, integrations, and divestitures.
Requirements
Bachelor's degree or equivalent in a scientific discipline.
At least 10 years of regulatory experience in the medical device industry.
Strong knowledge of medical device regulations, including the CE Marking process, global regulatory strategy, and regulatory submission process.
Proven experience in managing relationships with regulatory agency personnel and driving proactive initiatives to ensure compliance.
What We Offer
Competitive compensation package, including a comprehensive benefits program and opportunities for professional growth and development.
Collaborative and dynamic work environment with a team of experienced professionals.
The opportunity to work on challenging projects and contribute to the company's mission to discover and deliver innovative medicines and solutions.
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Pleasanton, California, United States AbbVie Full timeJob OverviewAbbVie is seeking a highly skilled Director of Regulatory Affairs to support the company's Body Contouring devices for marketed products. The successful candidate will be responsible for coordinating and managing global submissions to support renewals, registrations, and new submissions.The ideal candidate will have a strong background in medical...
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