This job listing has expired and the position may no longer be open for hire.

Regulatory Specialist 3 at Acumed LLC

Posted in Admin - Clerical 30+ days ago.

Location: Hillsboro, Oregon





Job Description:


Acumed LLC


Full time
JR0000007663


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.

About Us

Acumed is a global leader of innovative orthopaedic and medical solutions developed to improve patient care. With over three decades of experience in the orthopaedic industry, our mission is to aid the afflicted through the ingenuity of our minds, the labor of our hands and the compassion of our hearts. The company is headquartered in Hillsboro, Oregon with a global sales and distribution network supported by offices worldwide.

Regulatory Specialist 3

The Regulatory Specialist 3 provides regulatory perspective and expertise to cross-functional teams to assure products can be registered and are in compliance with relevant medical device standards, codes and regulations. S/he provides medical device regulatory input to product labeling, including but not limited to product labels, Instructions for Use (IFUs), surgical techniques and translations. S/he develops and executes regulatory strategy and integrates regulatory requirements throughout the product lifecycle. S/he relies on ongoing experience and judgment to plan, create, develop and maintain materials needed for regulatory compliance. She/ uses technical knowledge to drive new product submissions, listings, and registration of medical devices. Trains and mentors lower level specialists in regulatory activities.

Responsibilities


  • Initiates and maintains required establishment registrations including renewal or changes.

  • Ensures regulatory compliance of product and processes through management of department or interdepartmental process updates.

  • Assists in development of company regulatory strategies and prioritization.

  • Attends meetings and/or follows trade organizations and publications to stay aware of emerging issues across the globe.

  • Operates with a high level of independence.

  • Trains and mentors key personnel on new or existing regulatory policies and processes as well as emerging issues and changes in related procedures.



Qualifications

  • Bachelor of Science in science and/or engineering field and 6+ years of regulatory experience in medical device or equivalent industry, or Masters of Science in science and/or engineering field and 5+ years of regulatory experience in medical device or equivalent

  • Regulatory Affairs Certification (RAC) preferred.

  • Evidence of applied knowledge of applicable FDA, ISO, EU, and/or other region-specific medical device regulations, requirements and standards.

  • Ability to work independently with FDA, Notified Body, EU Authorized Representatives, 3rd party license holders and other global regulatory agencies.

  • Able to manage multiple projects simultaneously.

  • Proven record of strong teamwork and creative/strategic thinking.

  • Ability to work well with others, support regulatory activities and mentor/train others.

  • Excellent written and verbal communication skills.

  • Ability to read and speak English sufficiently to read, understand and complete all documentation.





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.

As an equal opportunity employer, Acumed is committed to providing reasonable accommodations to applicants with disabilities. If you are interested in applying to Acumed and need special assistance or accommodation, please contact us at recruiting@acumed.net.

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.

PI184101874


More jobs in Hillsboro, Oregon


Hotfoot Recruiters

Best Buy

Best Buy
More jobs in Admin - Clerical


Oldcastle BuildingEnvelope, Inc.

Environmental Resources Management, Inc.

Greif Packaging LLC