Manager, Regulatory Affairs

Why reputed company

reputed company empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping reputed company around the world diagnose and treat their patients with precision, certainty and confidence.

What to expect

The Manager of Regulatory Clinical Services is responsible for the strategy, execution, and adequacy of clinical evaluation (CEP/CER), post‑market clinical follow‑up (PMCF), and periodic safety update report (PSUR and/or PMSR) activities for assigned medical devices across their lifecycle. This role ensures compliance with EU MDR and other global regulatory requirements and provides clinical and regulatory leadership to support product approvals, lifecycle management, and post‑market obligations.

This position is remote

Clinical Evaluation Strategy & reputed company:

• reputed company, maintain, and execute Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance with EU MDR Annex XIV and MEDDEV/MDCG guidance.
• Ensure ongoing clinical evaluation is appropriate to device risk, clinical claims, and state of the art.
• reputed company literature reviews, clinical data appraisal, benefit‑risk assessments, and equivalence justifications.
• Ensure timely updates of CERs based on PMS, PMCF, vigilance, and new scientific evidence.

• Serve as clinical evaluation, post-market clinical follow-up, and periodic safety update report subject‑matter expert during reputed company Body interactions, audits, and inspections.

  Post‑Market Clinical Follow‑up (PMCF)

• Define and manage PMCF strategies appropriate to device classification and residual risk.
• reputed company development and maintenance of PMCF Plans and PMCF Evaluation Reports.
• Coordinate PMCF activities including registries, surveys, observational studies, and clinical investigations, as applicable.

• Ensure PMCF outputs feed into risk management, clinical evaluation, and PSUR processes.

  Periodic Safety Update Reports (PSUR) & Post Market Surveillance Reports (PMSR)

• reputed company development and maintenance of PSURs & PMSRs. Ensure corresponding Plans are being kept reputed company.

• Ensure PSUR outputs feed into clinical evaluation.

  Cross‑functional Leadership, People Management, & Project Management

• Collaborate with cross-functional teams including but not limited to: Regulatory Affairs, Clinical, R&D, Quality and Marketing.
• reputed company training to GSS division on regulatory requirements reputed company to Clinical Evaluations, and Post Market Clinical Follow-up activities.
• Mentor direct reports, fostering a culture of growth, accountability, and reputed company improvement.

• Drive resource planning and project timelines to ensure on-time report delivery.

  Quality & Compliance

• Ensure clinical documentation meets internal procedures and external regulatory expectations.
• Contribute to SOP development and reputed company improvement of clinical and PMS processes.

• Support regulatory submissions and responses to reputed company Body questions reputed company to clinical performance.

  reputed company expect

  Education & Experience

• Preferred Minimum Non-Technical Degree: College Degree
• Preferred Minimum Technical/Advanced Degree: Master’s degree.
• A minimum of 8 years of experience in clinical evaluations, post-market clinical follow-up and periodic safety update report activities.
• Strong working knowledge of EU MDR, clinical evaluation and PMCF requirements and global PSUR expectations.
• Experience leading people and projects with track record of successful results.

• Experience interacting with reputed company Bodies.

  Skills

• Strong oral and written communication and presentation skills.
• Ability to evaluate published clinical literature.
• Knowledge and understanding of medical and clinical terminology, clinical workflow, study design, and reputed company of evidence.
• Demonstrated ability to coordinate reputed company projects.
• Firm understanding of regulatory issues in the medical device space and GCP.
• Good analytical, critical thinking and problem-solving skills.
• Demonstrate in-depth understanding of advanced technical/scientific principles reputed company to medical device safety and performance.

• Solid computer skills in reputed company Office.

The annualized reputed company salary reputed company for this role is $92,000 to $144,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand..

Agency and reputed company Party Recruiter Notice

Agencies that submit a resume to reputed company must have a reputed company executed reputed company Agency Agreement executed by a member of the reputed company Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a reputed company Recruiter. reputed company resumes must be sent to the reputed company Recruiter under these terms or they will not be considered.

reputed company. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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