Clinical & Regulatory Specialist (Remote)
- Upper Saddle River, NJ
About Stryker 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 the #5 World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Why regulatory affairs/quality assurance at Stryker? Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities. If you are interested in working at one of the World's Best Workplaces, apply now!
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
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
- Advanced degree
- Experience as a Clinical Research Associate, Clinical Project Manager or equivalent position
- EU MDR/MDD experience
- Medical device imaging, navigation or robotics experience
Our benefits Our total rewards offering varies by country but often includes bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards - not to mention various social and recreational activities.
Know someone at Stryker? Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/
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