Post Market Surveillance Specialist 2

Acumed LLC

Come join a team where People make the difference! As a part of Marmon Holdings, Inc., a highly decentralized organization, we rely heavily on people with the aptitude, attitude, and entrepreneurial spirit to drive our success, and we're committed to attracting and retaining top talent.

Job Scope:
The Post Market Surveillance (PMS) Specialist II manages post-market activities for medical devices, including recalls, field actions, complaints, PSURs, PMCF, and other PMS tasks.

Responsibilities:

• Manage device recalls, field safety corrective actions (FSCA), and field actions in compliance with regulatory requirements (US, EU, global).
• Oversee complaint intake, investigation, and reporting, ensuring compliance with global regulations (FDA, MDR, etc.).
• Prepare PSURs and post-market surveillance documentation for regulatory submissions, tracking safety signals and trends.
• Develop and implement PMCF plans, supporting data collection and analysis for ongoing product safety and performance.
• Ensure compliance with regulatory requirements (FDA, EU MDR, etc.) and stay updated on global regulations.
• Prepare accurate technical documentation, including reports, notifications, and risk assessments.
• Collaborate with Quality, Regulatory, Clinical, and R&D teams to share post-market insights and support risk management and CAPA processes.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related field
• 3-5 years of experience in post-market surveillance, quality, or regulatory roles in the medical device industry
• Strong knowledge of FDA (21 CFR Part 803, 820), EU MDR, ISO 13485, and ISO 14971
• Experience with device recalls, field actions, complaints, and PMS in US, EU, and international markets
• Experience preparing PSURs, PMCF plans, and other post-market documentation
• Strong organizational, technical writing, and analytical skills
• Ability to manage multiple projects and collaborate cross-functionally
• Knowledge of medical device safety regulations and industry best practices
• Regulatory Affairs Certification (RAC) is a plus

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [email protected], and please be sure to include the title and the location of the position for which you are applying.