Regulatory Specialist 2 (EU Focus)

Company: Acumed

Position: Regulatory Specialist 2

Location: Remote

Posted: November 9, 2020

Apply Here: https://acumed.applicantpro.com/jobs/1577962.html

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 2

The Regulatory Specialist helps create, develop and maintain materials needed for regulatory compliance. Assists with company compliance activities, new product submissions, listings, and registration of medical devices. Works independently as necessary.

Duties/Responsibilities

  1. The ideal candidate would have experience obtaining/maintaining CE mark for medical devices.
  2. Understands regulations, follows complex directions, and investigates regulations when clarification is needed.
  3. Develops a working knowledge of the medical device regulations for assigned territories including, but not limited to: registration, labelling, and post-market surveillance requirements.
  4. In alignment with applicable strategies and plans and with support of team members, determines appropriate documentation and testing required for registration or renewal of Acumed products and coordinates with functional team members to obtain and provide this information for assigned markets.
  5. Prepares, organizes, and coordinates data for submission to and manages correspondence with the regulatory and standards agencies or organizations such as FDA, EU Notified Body, Health Canada, EU Authorized Representative, and 3rd Party License Holders.
  6. Works with team members to conduct documentation reviews and change assessments including evaluation of effects of regulatory, design, and manufacturing changes, and helps determine required regulatory action (e.g. submissions, notifications) for assigned markets.
  7. Assists in development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.), and may review and provide feedback on labelling and advertisement/promotional material to assure regulatory compliance.
  8. Provides regulatory perspective to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations.
  9. Reports relevant regulation and standards changes for assigned markets and helps determine impact and/or appropriate action.
  10. Assures regulatory compliance and content accuracy of technical documentation and submissions.
  11. Completes research and other related assignments as required.
  12. Develops an expertise of the medical device regulations for assigned territories.
  13. Determines applicable strategies and plans for registration or renewal of Acumed products for assigned markets and works with functional and cross-functional team members to create, obtain and provide this information.
  14. Works on development, organization, and application of labeling (e.g. instructions for use, marketing materials, package labels, etc.); reviews and approves labelling and advertisement/promotional material to assure regulatory compliance.
  15. Provides regulatory perspective and expertise to cross-functional teams (e.g. product development, risk management) to assure products are compliant with relevant US and international medical device standards, codes and regulations.
  16. Reports relevant regulation and standards changes for assigned markets, determines impact and takes appropriate action.
  17. Ensures regulatory compliance of products and processes through participation in department or interdepartmental process updates.
  18. Attends meetings and/or follows trade organizations and publications to develop understanding of requirements in assigned markets.
  19. Trains and mentors team members on new or existing regulatory policies and processes in assigned markets.

Qualifications

  1. Bachelor of Science in science and/or engineering field and field 3 - 5 years of regulatory experience in medical device or equivalent industry.
  2. Thorough working knowledge of applicable FDA, ISO, EU and/or other region-specific medical device regulations, requirements and standards.
  3. Ability to work under limited supervision with FDA, Notified Body, Authorized Representatives, 3rd party license holders and other global regulatory agencies.
  4. Ability to support and execute activities related to product development teams and projects.
  5. Ability to work well with others and manage projects.
  6. Excellent written and verbal communication skills.
  7. Ability to read and speak English sufficiently to read, understand and complete all documentation.

Acumed is an equal opportunity employers. 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 [email protected].