Manager, Global Vigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide direction and oversight for post-market surveillance initiatives that ensure the safety, performance, quality, and regulatory compliance of medical devices.

• Manage personnel within the Global Post-Market Surveillance team, specifically the Field Action Specialist group.

• Set priorities, distribute work and resources, mentor and develop staff, and guarantee adequate training and coverage.

• Supervise post-market surveillance procedures, including field actions, vigilance reporting, complaint analysis, trending, signal detection, post-market data reviews, and regulatory filings.

• Collaborate with departments such as Complaint Management, Regulatory Affairs, Quality, Medical or Clinical Affairs, Product Safety, Engineering, Operations, Commercial, Legal, and others.

• Develop, assess, and present PMS metrics, product concerns, vigilance performance, field action statuses, and process efficiencies to management and governance committees.

• Assist in the evaluation, documentation, escalation, and submission of potentially reportable events.

• Aid in the preparation, review, or endorsement of vigilance, follow-up, supplemental, trend, and regulatory authority reports.

• Analyze post-market data to detect trends, signals, changes in product issues, and support investigations and escalations.

• Lead global field actions which may include recalls, corrections and removals, Field Safety Corrective Actions, Field Safety Notices, product corrections, safety alerts, and jurisdiction-specific actions.

• Direct cross-functional field action teams from initiation to formal closure.

• Stay informed about global post-market surveillance requirements and assist in procedures, training, metrics, process enhancements, audits, inspections, resource planning, and management reporting.

• Support departmental planning regarding headcount, budgeting, training, and systems needs.

• Participate in staff selection, development, performance evaluations, merit recommendations, and promotions.

• Ensure staff training and adherence to company policies, Privacy/HIPAA regulations, and legal and regulatory standards.

⛳️ Requirements

• Bachelor’s degree in engineering, life sciences, nursing, pharmacy, regulatory affairs, quality assurance, business, project management, or a related field, or equivalent education and relevant work experience.

• Eight years of progressively responsible experience in regulated life sciences.

• Five years of experience in post-market surveillance or a closely related role.

• Two years of formal management, supervisory, or equivalent team leadership experience.

• Experience with electronic quality management systems, complaint handling, regulatory reporting, or similar post-market surveillance systems.

• Proficiency in standard business applications.

• Comprehensive understanding of medical device post-market surveillance, including field actions, complaint handling and analysis, vigilance and adverse event reporting, trending, signal detection, risk management, and quality system principles.

• Proven people-management abilities, encompassing prioritization, delegation, coaching, performance management, and employee development.

• Experience leading intricate cross-functional projects.

• Background supporting regulatory inspections, audits, or interactions with regulatory authorities.

• Proven project management skills.

• Strong analytical and problem-solving capabilities.

• Excellent written and verbal communication skills, including regulatory, technical, customer-facing, and executive-level interactions.

• Ability to influence and ensure accountable execution across functions and regions without solely relying on direct reporting authority.

• Skilled in conveying departmental or area issues and results, as well as presenting technical information.

• Proficient in leading collaborative team efforts and organizing resources to meet team objectives.

• Capability to make and prioritize process and resource decisions based on the overall needs of the team.

• Must be authorized to work for any employer in the United States.

• Successful completion of a pre-employment drug test and background check is required.

• Experience with connected, software-driven, drug-delivery, durable medical equipment, or other complex medical devices is preferred.

• Direct experience with medical device field actions, including recalls, corrections and removals, Field Safety Corrective Actions, international vigilance reporting, complaint trending, or signal detection is preferred.

• Formal project management training or certification (e.g., PMP) and/or quality or regulatory certification is preferred.

🏝️ Benefits

• Medical, dental, and vision benefits available from the first day.

• Health savings accounts.

• Flexible spending accounts.

• 11 paid holidays per year.

• Minimum of 20 days of paid time off, with accrual starting on day 1.

• 401(k) plan with company match.

• Employee Stock Purchase Plan.

• Bonus and competitive compensation package.

• Fully remote work within the United States.

• Equipment provided.

• Virtual training.