We are searching for a Regulatory and Quality Manager for our client that makes state-of-the-art medical equipment. This small division is located between Madison and Milwaukee, WI. You will be managing their products regulatory and quality processes, not a team of people. The Regulatory and Quality Manager will be responsible for all regulatory and quality compliance of their products.
No sponsorship is available.
What you will be doing:
- Track all external regulations which apply to the company's products including: quality, safety, performance, registration, submittals, and regulations from International and USA Federal/State agencies.
- Promote regulatory compliance within the company to ensure long term market stability, high customer satisfaction, and to protect the company from costly mitigations (recall, warning letters, etc.).
- Manage response to adverse regulatory action (recalls, warning letters, customs rejection, etc.).
- Support official approval efforts by international distributors of company products (approval to market, sell and service).
- Prepare 51OK and PMA submittals to FDA for new / improved claims.
- Monitor Form 2579 reporting process to ensure compliance with FDA and state requirements.
- Provide regulatory input to marketing and engineering for new features / products and / or changes to existing products.
- Execute internal and external auditing, complaint handling and CAPA Management.
- Maintain technical files and write formal procedures for all company products.
What they want you to have:
- BS degree in a technical field and 3+ years of hands-on medical device/equipment regulatory and quality experience. An Associates degree with greater experience will be considered.
- A "hands on" professional who will complete their own documentation.
- Medical FDA and EC performance standards experience is required.
- Auditing experience both internal and external.
- Any experience with UL, FDA 21 QSR820, ISO 13485:2016, or European MDD or MDR is a plus.
- Any experience with x-ray, scanning or MRI related equipment is a strong plus.
- Some limited travel is expected.
- Attractive salary
- Health insurance, presently 80% paid by company
- Short-term and long-term disability insurance
- 401k plan with match
- Vacation, holidays and sick days