DePuy Synthes, a member of Johnson & Johnson's Family of Companies, is recruiting for a Regulatory Affairs Specialist 2. The position will be based in Raynham, MA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, more agile and better equipped to meet the needs of today’s evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Regulatory Affairs Specialist 2 will:
• Responsible for supporting activities that initiate and maintain international product approvals for Wave 2b and 3 countries for Mitek.
• Partnering closely with other members of the Strategy Implementation Group, Dossier Excellence, Regional Portfolio Leads and Regulatory Operations teams.
• Provides support for Wave 2b and 3 market registrations and license renewals.
• Providing documentation to support international registration and tender requests.
• Prepares responses to questions and requests from health authorities for product registrations.
• Managing a significant amount of proprietary information in a confidential manner to prevent loss of intellectual property.
• Ensures compliance with regulatory agency regulations and interpretations
• Provides solutions to a variety of problems of moderate scope of complexity.
• Maintains and archives all regulatory documentation.
• A minimum of a Bachelor’s degree is required, preferably within a technical related discipline.
• A minimum of 2 years of related experience is required, preferably in Medical Devices or Pharmaceuticals.
• Ability to work both independently and in a team environment is required.
• Ability to problem solve, recognize and find solutions for gaps in processes is required.
• Knowledge of Medical Device regulations is preferred.
• Excellent verbal and written communication skills are required.
• Strong organizational, project management, problem solving, and presentation skills are required.
• This position is located in Raynham, MA and may require up to 10% travel.
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Depuy Orthopaedics. Inc. (6029)
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