- Work fully remotely
- Growing company, amazing benefits package
About Our Client
Our client is an established Medical Device Manufacturer that has been in business for over 100 years. They seek a Regulatory Specialist that will report to their US Head of Regulatory. Their site has over 175 employees, with a total of 225 throughout North America. Their products serve urology, surgery, gynecology and spine surgery.
- 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 $80,000
- Comprehensive benefits including medical, dental and vision through BCBS
- Flexible Spending Account
- Life and AD&D Insurance
- Disability Insurance
- 401k Match - 2% Automatic Enrollment
- Tuition Reimbursement
- Paid Parental Leave
- WORK REMOTELY