Manager, Regulatory Affairs

Hologic•Marlborough, MA

17h•$92,000 - $144,000•Remote

About The Position

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

Requirements

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 Notified Bodies.
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 levels of evidence.
Demonstrated ability to coordinate complex 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 related to medical device safety and performance.
Solid computer skills in Microsoft Office.

Responsibilities

Clinical Evaluation Strategy & Oversight:
Develop, 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.
Oversee 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 Notified Body interactions, audits, and inspections.
Post‑Market Clinical Follow‑up (PMCF)
Define and manage PMCF strategies appropriate to device classification and residual risk.
Oversee 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)
Oversee development and maintenance of PSURs & PMSRs. Ensure corresponding Plans are being kept current.
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.
Provide training to GSS division on regulatory requirements related to Clinical Evaluations, and Post Market Clinical Follow-up activities.
Mentor direct reports, fostering a culture of growth, accountability, and continuous 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 continuous improvement of clinical and PMS processes.
Support regulatory submissions and responses to Notified Body questions related to clinical performance.