Job Description:

Acumed LLC


Position Title: Post Market Surveillance Specialist 2

Company: Acumed LLC

Reg ID: JR0000031045


Location: Addison, TX
Hillsboro, OR

Time Type: Full time


Description:

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 careers@marmon.com, and please be sure to include the title and the location of the position for which you are applying.

About Us:

With more than 100 autonomous manufacturing and service businesses, Marmon Holdings, Inc. may be the biggest company you’ve never heard of. Part of Berkshire Hathaway Inc., Marmon is a global industrial organization comprising 11 diverse groups with 20,000-plus employees and $10 billion in annual revenue.

As leaders in every industry we serve, Marmon companies have earned a great degree of independence. And our people thrive on an entrepreneurial spirit. At the same time, our group structure gives every Marmon company access to the expertise of other Marmon companies serving the same or related markets and customers – all with the support of the entire Marmon organization.

Working together, we become something more than the sum of our parts. We become the most reliable solution provider for a broad range of industries and customers worldwide.

In every case, Marmon’s success is due to our people. People with talent, drive and high ethical standards. People who are following their passions and building their careers across Marmon.

Want to learn and perfect your craft? Want to sharpen your skills while helping to solve challenges for our customers and our world? Looking for a chance to grow within – or perhaps outside – your field? Find a Marmon company that matches your passion. And see what you can do with the support of a team that values your contribution.

Acumed is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with a disability.

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