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Senior Manager, Regulatory Affairs-4358130320
DePuy Orthopaedics, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Regulatory Affairs located in Warsaw, Indiana.
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.
DePuy Orthopaedics is the Joint Reconstruction business offering orthopaedic devices, solutions and supplies for hip, knee and extremity reconstruction, in addition to cement and operating room products.
The Senior Manager, Regulatory Affairs has responsibility for managing the Regulatory Submissions team and budget. He/she will be responsible for developing US and International regulatory strategies and interfacing with regulatory agencies and marketing/engineering regarding strategies and submissions. This individual will be responsible for independently preparing and submitting regulatory submissions for the US, including 510(k)s, PMAs, PMA supplements, IDEs, minor modifications. This individual will prepare original technical files, design dossiers, technical file revisions, STEDs and other documents for the Global market. He/she will also be responsible for reviewing all submissions prepared by the Regulatory Submissions group. He/she will review labeling and advertising to ensure compliance with FDA regulations.
The Senior Manager, Regulatory Affairs will perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information. He/she will know, understand, incorporate and comply with all applicable laws and regulations relating to DePuy's business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct. This individual will obtain approval of new products and regulatory support for marketed products, provides guidance and interpretation of global regulatory requirements to help ensure efficient use of product resources, and oversees responses to regulatory questions and correspondence. The Senior Manager, Regulatory Affairs will manage and/or prepare regulatory submissions and files, including 510(k)s, PMAs, PMA supplements, IDEs, Minor Modifications, technical files, design dossiers, technical file revisions, STEDs and other documents international submissions. he/she will interact with regulatory agencies to resolve matters and expedite the approval process, provides regulatory guidance to project teams, evaluates product and process changes and deviations for regulatory compliance, and conducts labeling and advertising review. This individual will administer budget, performance reviews and development planning for staff.
A minimum of a Bachelor's Degree is required. A Bachelors Degree in biological sciences, bioengineering and/or related medical/health fields is preferred. An Advanced Degree is preferred. A minimum of 10 years experience in regulatory affairs within a regulated healthcare environment or industry is required. Medical device experience is highly preferred. A minimum of 3 years supervisory experience is required. Experience being responsible for independently preparing and submitting regulatory submissions for the US is required. Experience in writing, or the ability to write, 510(k)s, PMAs, PMA supplements and minor modifications is required. Experience with design dossiers, technical file revisions, STEDs and other documents for the Global market preferred. IDE experience is an asset. The ability to build and lead talent development for a large team is required. Above average oral and written communication skills employing tact and diplomacy and tactical regulatory and business knowledge to gain approval and ensure maintenance of legal marketing status of all products is required. Broad-based technical knowledge and skills in diverse areas of business (e.g., R&D, Operation, Marketing, etc.) is required. The ability to effectively negotiate and influence peers, affiliates and regulatory agencies to ensure that regulatory and business needs are met is required.
This position is located in Warsaw, IN and will require up to 10% travel, including some light international.
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Primary Location: North America-United States-Indiana-Warsaw
Organization: Depuy Orthopaedics. Inc. (6029)
Job : Regulatory Affairs
Travel: Yes, 10% of the time
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