DePuy Synthes Companies of Johnson & Johnson is seeking a Clinical Regulatory Specialist II located in West Chester, PA.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in 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 Clinical Regulatory Specialist II, will be responsible for supporting Health Hazard Evaluation and Field Action execution activities. Some key activities include:
• Represents patient safety/medical interests on multi-disciplinary teams,
• Collaborates with Field Action Investigators, Product Development, and Manufacturing to produce an accurate and complete Health Hazard Evaluation,
• Reviews product complaints for similar/ related issues in assisting in determination of observed occurrence rate,
• Identifies potential patient harms related to the issue under investigation in conjunction with the Medical Safety Officer,
• Presents Health Hazard Evaluation (complaints and medical input) to Executive Management,
• Lead Field Action Strategy meetings,
• Preparation of document packages to notify regulatory agencies of field action activities,
• Communicating updates to FDA and global regulatory agencies,
• Processing/executing, and closing Field Actions in a timely manner, and
• Support FDA and regulatory inspections. Qualifications
• To be considered for the role a minimum of a Bachelor’s Degree in Nursing, Life Sciences or Health Sciences is required.
• A minimum of 2 years of professional experience is required.
• A minimum of 1 year in a medical device and/or pharmaceutical industry is required.
• A current RN license or an advanced practicing license (i.e. PA, APRN, etc.) is strongly preferred.
• RAC or ASQ certifications are preferred.
• Experience in regulatory affairs, post market regulatory, quality or compliance areas is preferred.
• Working knowledge of 21 CFR Part 820, QSR, ISO 13485, CFR 806, and MDD/IVDD requirements is preferred.
• Experience with health authority reporting preferred.
• The ability to work independently and prioritize with little supervision is required.
• Strong written and oral communication and interpersonal (listening) skills is required.
• The ability to lead efforts aimed at the identification of problematic situations, reporting issues, and the development of resolutions and decision making is required.
• Analytical and critical thinking skills are required.
• Excellent organizational and time management skills are required.
• Strict attention to detail is required.
• The ability to work autonomously and on multiple projects with accelerated timelines is required.
• Proven ability to meet timelines is required.
• Excellent computer (e.g., PowerPoint, WORD, Excel, Visio), communication, and written skills are required.
• This position will be based in West Chester, PA and will require up to 10% travel, including potential international.
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United States-Pennsylvania-West ChesterOrganization
Depuy Orthopaedics. Inc. (6029)Job Function