The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Clinical Regulatory Specialist to join our Spine division to be based in Allendale, New Jersey; Leesburg, Virginia; Shirley, Massachusetts or remotely anywhere within the United States.
Who we want
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Collaborative partners. People who build and leverage cross-functional relationships to bring ideas, data and insights to drive continuous improvement in functions.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What you will do
As a Clinical Affairs/CER Regulatory Specialist, you oversee the completion of Clinical Evaluation Reports (CERs) and address Regulatory Body questions requiring clinical data support. You lead Medical Affairs efforts in the development and execution of strategies to obtain information and support concerning medical devices undergoing clinical investigation, post market surveillance or marketed/product use evaluation. This includes activities such as generating clinical plans for New Product Development, fulfilling reporting requirements for FDA clearance/approvals and CE Marking and reviewing and approving collateral material containing clinical data. These activities will facilitate worldwide registration and introduction of new products and provide clinical data and publications of market support and reimbursement of approved devices. You serve as an active member of hub and spoke teams to establish, implement, and maintain Global Regulatory and Quality processes and documents supporting our Global Quality Management Systems.
Responsibilities may include but are not limited to:
Divisional Process Owner (DPO) for Medical Affairs procedures including authoring and revising standard operating procedures (SOPs) to meet all corporate and regulatory requirements. You are accountable for representing procedures in internal and external audits, responding to and revising procedures according to any findings and overseeing the documents of external origin process.
Create and manage detailed project schedule for Clinical Evaluation and Post Market Clinical Follow-Up processes
Follow up (PMCF) plans and reports, and Summary of Safety and Clinical Performance (SSCP) documents
Facilitate project plan input, review audit study data or reports, prepare clinical sections of US or EU regulatory documentation
Collaborate with Regulatory Affairs in submission of IDEs, pre-market approval applications, amendments, supplements, and other regulatory submissions regarding clinical issues
Participate as the clinical representative on product development teams, including generation of the clinical plan
Represent the clinical team cross-functionally for activities including change control, risk management, and collateral review
Oversee and guide Clinical Study Managers in the preparation and development of study protocols and data collection strategies to aid regulatory commitments and marketing claims; make recommendations for statistical analyses
Oversee or prepare annual study progress reports and final reports, to include clinical and radiographic data, for regulatory agencies, Investigators and IRBs/ECs
Act as liaison with company business units to identify strategies to bring new products to market which require or would benefit from clinical trial data
Analyze clinical trial data throughout the study as it relates to pre-market or PMCF requirements; make recommendations for any modifications to the plans or protocols
Participate in preparation of clinical research operating plans and objectives, maintaining alignment with company and departmental strategies
What you need
Bachelor's degree required
Minimum 4 years of professional experience preferably as a Clinical Research Associate, Clinical Project Manager or equivalent position supporting Clinical or Medical Affairs/Research, Regulatory Affairs or Medical Writing
Experience evaluating or drafting CERs required
Medical device experience
Clinical and regulatory knowledge of regulations and experience preparing clinical sections of regulatory documents for FDA and international agencies
Experience as a Clinical Research Associate, Clinical Project Manager or equivalent position
EU MDR/MDD experience
Medical device imaging, navigation or robotics experience
Internal Number: R441883
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com