Full Job Description
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 Senior Clinical and Regulatory Specialist to join our Spine division to be based in Allendale, New Jersey; Leesburg, Virginia or Shirley, Massachusetts.
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 Senior Clinical and 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; Advanced degree preferred
Minimum 7 years professional experience with at least 5 years as a combination of Clinical or Medical Affairs/Research, Regulatory Affairs or Medical Writing
Experience evaluating or drafting CERs required; EU MDR/MDD experience preferred
Medical device experience required; preferably in imaging, navigation or robotics
Clinical and regulatory knowledge of regulations and experience preparing clinical sections of regulatory documents for FDA and international agencies
Work From Home: Occasional
Travel Percentage: 20%
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.
Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.