This role is hybrid three days a week in our Parsippany, NJ office
The Global Medical Safety Lead serves as the company's subject matter expert for medical safety, risk management, and post-market surveillance. You will be responsible for monitoring, evaluating, managing, and communicating the safety profile of embecta products across global markets. Reporting to the Global Head of Medical Affairs & Human Factors, the successful candidate will drive safety excellence, ensure regulatory compliance and support strategic initiatives that enhance patient safety and business performance.
What You'll Be Doing:
Medical Safety Leadership
- Serve as embecta's global medical safety expert and primary resource for medical safety matters.
- Provide strategic direction and expert guidance on medical safety matters to senior leadership and cross-functional stakeholders.
- Support the development and continuous improvement of Medical Affairs policies, procedures, and governance frameworks, bringing recommendations to the Head of Medical Affairs.
- Serve as a role model in fostering a strong Medical Affairs and Clinical Affairs culture across the organization.
Post-Market Surveillance & Compliance
- Drive post-market surveillance activities and trending analyses to identify emerging safety risks.
- Support regulatory submissions and responses related to product safety
- Maintain compliance with FDA, MDR, and other applicable global regulatory requirements.
- Support inspections, audits, and audit readiness activities.
Strategic Initiatives
- Lead initiatives to modernize and strengthen medical safety infrastructure, including implementation of emerging technologies and AI-enabled platforms.
- Establish and maintain Medical Safety governance, processes, methodologies, and review standards to ensure consistent and compliant safety decision-making.
- Lead development of risk management related documents, including Failure Mode and Effects Analysis (FMEA) Health Risk Assessments (HRA) Health Hazard Evaluations (HHE) Benefit-risk assessments Evaluations supporting field corrective actions and recalls
- Provide medical and clinical oversight for key regulatory and lifecycle documentation, including Clinical Evaluation Reports (CER) Post-Market Clinical Follow-Up (PMCF) Plans and Evaluation Reports Health Risk Assessments (HRA) PMS Reports and PSURs Clinical evidence and benefit-risk documentation.
Cross-Functional Collaboration
- Partner closely with Regulatory Affairs, Quality, Clinical, Human Factors, and Product Development teams to evaluate and mitigate product risks.
- Provide medical safety expertise during design changes, product launches, complaint investigations and regulatory submissions.
- Influence safety strategy and decision-making through clear communication of risk-benefit assessments.
What We're Looking For:
Required Qualifications:
- Advanced healthcare degree required (MD, DO, MBBS, PharmD, DNP, MSN, RN, or equivalent).
- Minimum 5 years of medical device safety, vigilance, post-market surveillance, or clinical safety experience
- Extensive experience supporting global regulatory submissions and lifecycle management activities.
- Demonstrated experience authoring, reviewing, or contributing to: Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) documentation Health Risk Assessments (HRA), Clinical Study Reports (CSR), PMS Reports and PSURs Vigilance and safety assessments.
- Strong experience with risk management methodologies, including FMEA and benefit-risk assessments.
- Proven expertise in medical device vigilance, complaint handling, signal detection, and post-market safety activities.
- Experience supporting FDA inspections, notified body audits, and regulatory authority interactions.
- Willingness to travel as needed (~10%)
Preferred Qualifications:
- Diabetes, injection device, or medical technology industry experience
- Current clinical licensure
- CPPS certification
Competitive base salary based on experience and qualifications: $158,000-$209,000 (subject to variation depending on physical location).
Posted salary ranges are provided in good faith. embecta reserves the right to adjust ranges depending on the selected candidate9s experience, qualifications, external market conditions, and internal equity considerations.
Base pay is one component of the Total Rewards package at embecta, which also includes eligibility foran annual bonus and an annual LTI award. Benefits include medical, dental, vision, retirement savings plans, and paid time off. More details about our benefits programs can be found on our Careers page.
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