Post Market Surveillance Specialist 1 - Military veterans preferred

Acumed LLC


Position Title: Post Market Surveillance Specialist 1

Company: Acumed LLC

Reg ID: JR0000037816


Location: USA_OR_Hillsboro_5885 NE Cornelius Pass Rd

Time Type: Full time


Description:

Acumed LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

Job Scope

The role of the Post Market Surveillance Specialist encompasses the responsibilities described below and additional functions based on experience and proven aptitude. Responsibilities in this role include timely and accurate medical device reports (MDRs) and vigilance reports and assistance with the complaint handling process. This role will support additional post market surveillance activities including but not limited to, recalls/field safety corrective actions, audits and inspections, and reporting to regulatory authorities as needed.

Responsibilities

• Lead efforts to establish and maintain procedures, work instructions, and templates associated with MDRs/Vigilance and/or Complaint Handling to maintain compliance with applicable regulations and standards.
• Lead the Adverse Event reporting program to ensure compliance; directly responsible for review and submission of regulatory reports (Medical Device Reporting, Vigilance Reporting, etc.) to governing regulatory agencies or authorities.
• Lead complaint handling activities to ensure timeliness of all complaint handling activities (e.g. Good Faith Efforts, product return and evaluation, complaint investigation, complaint closure).
• Manage preparation and reporting of MDR and Vigilance Reports to Quality Assurance department for monthly Quality Review and Management Review process and on as-needed basis.
• Participate and support internal audits, external audits, and inspections.
• Support Post Market Surveillance documentation updates as assigned.
• Support the preparation and coordination of device recalls, field safety corrective actions (FSCA), and field actions in compliance with regulatory requirements in various markets (US, EU, and global).
• Support and generate reports for complaints, adverse events, and recalls/field safety actions as assigned for regulatory compliance.
• All other duties as assigned.

Qualifications

• Bachelor’s degree in engineering or scientific discipline preferred.
• 2-3 years applicable experience in complaint handling/MDR/Vigilance capacity preferred.
• Experience in medical device, biologics, or pharmaceutical field preferred.
• Knowledge of 21 CFR Part 820, 21 CFR Part 803, ISO 13485:2016, ISO 14971:2019 (EN ISO 14971:2019), EU MDD, and EU MDR.
• Experience with US Class I and II, and EU Class I, II(a), II(b), and III medical devices. Experience with orthopedic devices strongly preferred.
• Demonstrated ability to work in a fast-paced environment and simultaneously manage multiple competing tasks and demands.
• Ability to work independently, take initiative, establish priorities, and meet deadlines.
• Capable of working effectively in cross-functional relationships and establishing clear roles and responsibilities.
• Strong communication skills, both verbal and written, including strong attention to detail in composing and proofing-reading materials.
• Strong analytical and data analysis skills, with strong statistical analysis skills preferred.
• Technical writing skills; knowledge of good documentation practices; able to write to different audiences.
• Strong proficiency with MS Office tools to include Word, Excel, PowerPoint, and Outlook.
• Ability to effectively present information to management, ancillary departments, and/or customers.

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:


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.



Equal employment opportunity, including veterans and individuals with disabilities.

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