Global Medical Safety Architect

Embecta Corp.; New Jersey; Hybrid; USD 158,000 - 209,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive (LTI)

Medical, dental, vision insurance

Retirement savings plan

Paid time off

Job summary

embecta is seeking a Global Medical Safety Lead to serve as the company’s subject matter expert for medical safety, risk management and post-market surveillance. You will monitor, evaluate, and communicate safety profiles across global markets, reporting to the Global Head of Medical Affairs & Human Factors.

You will drive safety excellence, support regulatory submissions, and lead initiatives to modernize safety infrastructure, including technology and AI-enabled platforms, while collaborating

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.
• Experience authoring/contributing to CERs, PMCF documentation, HRAs, CSR, PSURs.
• Strong risk management skills including FMEA and benefit-risk assessments.
• Experience with FDA inspections and regulatory authority interactions.

Responsibilities

• Lead medical safety as the global subject matter expert and guide safety decisions.
• Support regulatory submissions and post-market surveillance activities.
• Ensure compliance with FDA, MDR, and other global regulatory requirements.
• Develop risk management documents and governance frameworks.
• Collaborate with Regulatory, Quality, Clinical, and Product teams to mitigate risks.

Skills

Advanced healthcare degree

5+ years medical device safety

Global regulatory submissions

CER/PMCF documentation

FMEA & HRA risk assessments

FDA inspections experience

Vigilance and safety assessments

Willingness to travel

Education

MD/DO/MBBS/PharmD/DNP/MSN/RN or equivalent

Job description

embecta is seeking a Global Medical Safety Lead to serve as the company’s subject matter expert for medical safety, risk management and post-market surveillance. You will monitor, evaluate, and communicate safety profiles across global markets, reporting to the Global Head of Medical Affairs & Human Factors.

You will drive safety excellence, support regulatory submissions, and lead initiatives to modernize safety infrastructure, including technology and AI-enabled platforms, while collaborating