Global Recall & Post-Market Surveillance Lead

Merit-Medical-Systems-Inc.; South Jordan (UT); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Medical/Dental & Other Insurances

Low Cost Onsite Medical Clinic

Two Onsite Cafeterias

Employee Garden | Gardening Classes

3 Weeks' Vacation | 1 Week Sick-Time |

Paid Holidays

401K | Health Savings Account

Job summary

Merit Medical seeks a skilled regulatory affairs professional to lead post‑market surveillance and field action recalls. The role coordinates recalls, FSCAs, and regulatory reporting across functions and regions to ensure timely, compliant actions.

The ideal candidate has 3–5 years in medical device quality and regulatory affairs, with strong knowledge of FDA/EU regulations, ISO 13485, and audits. Requires cross‑functional collaboration and excellent communication skills.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, Biomedical Sciences or a related discipline.
• Minimum 3–5 years of experience in medical device quality, regulatory affairs, post-market surveillance, complaint handling and vigilance reporting with field action recall focus.
• Strong knowledge of FDA regulations (21 CFR 803, 806, and Part 7), EU MDR 2017/745, ISO 13485, MDSAP, ISO 14971 and Canadian Medical Device Regulations.

Responsibilities

• Lead and coordinate product recalls, corrections, removals, market withdrawals and Field Safety Corrective Actions (FSCAs).
• Develop recall strategies, execution plans, communication plans and timelines.
• Coordinate field action activities with multiple internal teams and international affiliates.
• Ensure timely execution of recall planning, notices, effectiveness checks and product disposition activities.
• Prepare and submit documentation to FDA and international regulatory authorities; support inspections and audits.

Skills

Regulatory affairs

Post-market surveillance

Recall management

FDA regulations

Cross-functional coordination

Education

Bachelor's degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, Biomedical Sciences

Tools

Electronic quality systems

Databases

Microsoft Office

Job description

Merit Medical seeks a skilled regulatory affairs professional to lead post‑market surveillance and field action recalls. The role coordinates recalls, FSCAs, and regulatory reporting across functions and regions to ensure timely, compliant actions.

The ideal candidate has 3–5 years in medical device quality and regulatory affairs, with strong knowledge of FDA/EU regulations, ISO 13485, and audits. Requires cross‑functional collaboration and excellent communication skills.