Recall & Field Action Lead, Post-Market Surveillance

100 Merit Medical Systems, Inc.; South Jordan (UT); Vor Ort; USD 85.000 - 120.000; Vollzeit

Benefits dieser Stelle

Multiple shifts

Medical/Dental Insurance

Onsite medical clinic

Onsite cafeterias

3 weeks vacation

401K

Zusammenfassung

Merit Medical Systems, Inc. is seeking a Regulatory/Quality professional to lead adverse event reporting and field action activities across global operations.

You will coordinate recalls, manage regulatory submissions, and support inspections while ensuring compliance with FDA, EU MDR, ISO 13485, and related requirements. Strong project management and communication skills are essential.

Qualifikationen

• Bachelor's degree in Engineering, Life Sciences, QA, Regulatory Affairs, Biomedical Sciences.
• 3–5 years of experience in medical device quality, regulatory affairs, post-market surveillance, complaint handling, adverse event reporting, vigilance with field action recall focus.
• Experience with global medical device field action recall execution.
• Strong knowledge of FDA regulations (21 CFR 803, 806, 7), EU MDR 2017/745, ISO 13485, MDSAP, ISO 14971, and Canadian Medical Device Regulations.
• Strong project management, organizational, and time management skills.
• Excellent written and verbal communication skills.
• Proficiency with electronic quality systems, databases, spreadsheets, and Microsoft Office applications.
• Ability to manage multiple priorities and meet regulatory reporting deadlines.

Aufgaben

• Maintain and implement process improvements for the Global Adverse Event reporting system and related duties.
• Assist with post-market surveillance activities and field action management.
• Develop recall strategies, execution plans, communication plans, and timelines.
• Coordinate field action activities across departments and regions.
• Ensure compliance with FDA, EU, ISO, and regulatory requirements.
• Prepare, submit, and maintain regulatory reports and notifications.
• Support regulatory inspections, audits, and conformity assessments.
• Maintain inspection-ready documentation and records.

Kenntnisse

Regulatory affairs

Post-market surveillance

Adverse event reporting

Field action recall

Project management

Communication skills

Regulatory inspections

Data analysis

Quality systems

Ausbildung

Bachelor's degree in Engineering/Life Sciences/QA/Regulatory

Tools

Electronic quality systems

MS Office

Databases

Jobbeschreibung

Merit Medical Systems, Inc. is seeking a Regulatory/Quality professional to lead adverse event reporting and field action activities across global operations.

You will coordinate recalls, manage regulatory submissions, and support inspections while ensuring compliance with FDA, EU MDR, ISO 13485, and related requirements. Strong project management and communication skills are essential.