Regulatory Affairs Specialist - CMF-1227140730
Description
DePuy Synthes Companies of Johnson & Johnson is seeking a Regulatory Affairs Specialist - CMF in West Chester, PA.
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 Synthes Craniomaxillofacial (CMF) offers a complete array of neuro, craniomaxillofacial, thoracic and soft tissue implants for skeletal and soft tissue repair and reconstruction.
Responsibilities of the Regulatory Affairs Specialist – CMF include (but are not limited to) the following: Partner with cross functional teams by providing regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities. Review, assess, and provide regulatory authorization related to ongoing product design changes. Review and analyze technical protocols, data, and reports generated by Product Development, Operations, Clinical Research, Quality Assurance or other related departments. Assist in preparing and/or author U.S. submissions, including 510(k)’s, for a diverse range of bone and tissue repair products. Engage regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, etc. Maintain regulatory records, including the ongoing update of a database with regulatory information, and retaining and filing Regulatory paper documentation. Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations and device-specific regulatory clearances/approvals. Support field action investigations by providing and/or evaluating regulatory-related information. Prepare medical device listings, as well as obtain and maintain Certificates to Foreign Governments and Certificates for Export. Provide Regulatory Affairs support during internal and external audits. This person shall keep current in regard to US and Canadian regulations, guidance documents, Federal Register notices, and competitor news, and will assist in the development of best practices for Regulatory Affairs processes.
Qualifications
A minimum of a Bachelors Degree is required. A degree in engineering or scientific discipline is preferred. A minimum of 1 year of Regulatory Affairs experience is required OR an advanced degree with a minimum of 1 year of experience in a medical device regulatory environment will be considered. A solid knowledge of US FDA regulations and review processes is required. A successful track record in preparing submissions for Class II medical devices is preferred. Experience with pre-submissions, IDEs, and/or Class III devices (PMA or HDE) is preferred. Design Dossiers and Technical Files experience is preferred. Experience interacting with US FDA is preferred.
Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, succinctly and effectively over the phone and in writing. Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required. Ability to work as a member of a team in a timeline-driven environment with limited supervision is required. Being detail-oriented while having the ability to handle multiple ongoing projects/tasks is required.
This position will be located in West Chester, PA and may require up to 10% travel, including some light international.
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Primary Location:North America-United States-Pennsylvania-West Chester
Organization: Depuy Orthopaedics. Inc. (6029)
Job Function: Regulatory Affairs
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