Regulatory Affairs Manager- Medical Device Manufacturer

Buffalo Grove Permanent USD100,000 - USD130,000 per year
  • 31 Days of Time Off per year
  • Remote work flexibility

About Our Client

Our client is an established Medical Device Manufacturer that has been in business for many years. They seek a Regulatory Affairs Manager that will report to their US Head of Regulatory. Their site has over 300 employees and boast a close knit atmosphere that's extremely employee-centric. This is a new position due to continued growth and product development.

Job Description

  • Ensure projects are identified, organized, and completed in a thorough and timely manner.
  • Ensures timely, appropriate, and complete communication with FDA and other regulatory bodies
  • Executes the creation and submission of 510(k)s and associated labeling
  • Prepares 510(k) Decision Trees and Letters to File as required
  • Prepares and submits Annual Reports, Device Listings and facility registrations.
  • Independently creates updates, organizes, and maintains all regulatory documentation including Project Applications, Device Master Records, and Letters to File.
  • Leads Recall and associated field action activities
  • Complies with all applicable regulatory requirements for medical devices such as FDA Quality System Regulation, 21 CFR 820 & ISO 13485.
  • Reviews and approves device Labeling changes and updates
  • Maintains the schedule and supports actions to complete Product Applications and Product Card processes.
  • Executes the identification and implementation of new or changed applicable Laws and Standards
  • Executes creation and maintenance of vendor Quality Agreements
  • Keeps apprised of new and changing regulations, standards, policies, and guidance documents issued by relevant regulatory authorities..
  • Conducts training in Quality System Regulation, ISO Standards, and other International Regulations.
  • Investigates and recommends solutions to Quality and Regulatory issues and completes assigned projects.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • B.S. Degree; or 5 years appropriate experience necessary.
  • Must have working knowledge of Good Manufacturing Practices Requirements and experience in a regulated medical manufacturing environment, required
  • Experience with filing 510k's or equivalent experience registering medical devices outside the US.
  • Familiarity with medical device reprocessing desirable.
  • Excellent organizational skills and able to work independently.
  • Excellent communication skills.
  • Intermediate-Advanced PC experience with spreadsheets, letter writing and presentation applications

What's on Offer

  • Competitive base salary depending on experience, circa $100,000 - $130,000
  • Comprehensive benefits including medical, dental and vision through BCBS
  • Flexible Spending Account
  • Life and AD&D Insurance
  • Disability Insurance
Evan Gilbert
Quote job ref

Job summary

Life Sciences
Sub Sector
Regulatory Affairs
Industrial / Manufacturing
Buffalo Grove
Contract Type
Consultant name
Evan Gilbert
Job Reference