Regulatory Affairs Specialist - Medical Devices

MAI Animal Health; Elmwood (WI); On-site; USD 60,000 - 80,000; Full time

Job summary

A medical device company in Elmwood, Wisconsin is seeking a Regulatory Affairs Specialist. The role involves supporting regulatory compliance for medical device products, maintaining quality system requirements, and collaborating with Quality, Engineering, and Manufacturing teams. The ideal candidate should have a Bachelor's degree in a scientific discipline and a minimum of two years' experience in a regulated environment. Proficiency in ISO standards and FDA regulations is essential. The company values attention to detail and effective communication skills.

Qualifications

• Minimum of 2 years of experience in a regulated environment.
• Experience with electronics or medical devices preferred.
• Familiarity with cleanroom regulatory requirements is preferred.

Responsibilities

• Support regulatory compliance for medical device products.
• Maintain quality system requirements and assist with documentation.
• Participate in internal and external audits.
• Collaborate cross-functionally for regulatory activities.

Skills

ISO 13485 knowledge

FDA quality system requirements

Attention to detail

Effective communication

Proficiency in Microsoft Word, Excel, Outlook

Education

Bachelor’s degree in a scientific or related discipline

Tools

QMS software (QT9 or similar)

Job description

A medical device company in Elmwood, Wisconsin is seeking a Regulatory Affairs Specialist. The role involves supporting regulatory compliance for medical device products, maintaining quality system requirements, and collaborating with Quality, Engineering, and Manufacturing teams. The ideal candidate should have a Bachelor's degree in a scientific discipline and a minimum of two years' experience in a regulated environment. Proficiency in ISO standards and FDA regulations is essential. The company values attention to detail and effective communication skills.