Clinical Research Specialist

📋 Description

• Direct the clinical evidence strategy for the CST portfolio, which includes the creation and upkeep of Global Clinical Evidence Strategy (GCES) documentation that aligns with business objectives.

• Create, sustain, and periodically update PMCF Plans in accordance with EU MDR Annex XIV; evaluate evidence adequacy and implement PMCF activities (surveys, registries, observational studies) to address identified gaps.

• Incorporate PMCF results into CERs and associated documentation; assess the effect of incremental product modifications on the PMCF strategy.

• Collaborate with Clinical Operations on the design of PMCF studies and work alongside Medical Writing on CEPs, CERs, PMCFRs, and SSCPs.

• Partner with Regulatory Affairs, Quality, R&D, Medical Affairs, and Marketing on submissions, post-market evaluations, and claims verification.

• Assist in responding to inquiries from Notified Bodies and regulatory authorities; support surgeon engagements as required.

• Maintain strategic oversight of PMCF initiatives and ensure all documentation is up-to-date, traceable, and ready for audits.

⛳️ Requirements

• Bachelor's degree.

• A minimum of 2 years of relevant experience, or an advanced degree with no experience.

• Experience with EU MDR PMCF activities (preferred).

• Knowledge of medical device clinical documentation (PMCF, CER, CEP) (preferred).

• Familiarity with regulatory or audit support (preferred).

• Strong skills in cross-functional collaboration.

• High attention to detail in regulated environments.

• For bachelor's degrees obtained outside of the United States, a degree that meets the criteria of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

🏝️ Benefits

• Health, Dental, and Vision insurance.

• Health Savings Account.

• Healthcare Flexible Spending Account.

• Life insurance.

• Long-term disability leave.

• Dependent daycare spending account.

• Tuition assistance/reimbursement.

• Simple Steps (global well-being program).

• Incentive plans.

• 401(k) plan with employer contribution and matching.

• Short-term disability.

• Paid time off.

• Paid holidays.

• Employee Stock Purchase Plan.

• Employee Assistance Program.

• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums).

• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).