Regulatory and Quality Manager in Milwaukee, WI

$80K - $90K(Ladders Estimates)

Markent Personnel Inc   •  

Milwaukee, WI 53202

Industry: Pharmaceuticals & Biotech

  •  

Less than 5 years

Posted 56 days ago

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.


Benefits:

  • 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

Valid Through: 2019-11-11

$80K - $90K