Senior Regulatory Affairs Consultant

Posting Date: 01/15/2019
Closing Date: 02/15/2019
Posting Level: Executive/Senior Level

Fang Consulting specializes in Medical Device Regulatory Affairs and Quality Assurance/Engineering in the midst of Minnesota’s Medical Alley. Due to firm growth and continuing expansion, we are looking to add a Senior Regulatory Affairs Consultant to our team.

We’re committed to finding a collaborative professional who brings to work each day his/her unique perspective and drive to serve as a trusted partner to help solve our clients’ biggest challenges.

If you are interested in working in a dynamic atmosphere—our work is serious but our office is fun—and can flex to meet the demands of our emerging and Fortune 500 clients alike, we’d love to hear from you!

What you will do:
• Prepare US and OUS regulatory submissions: 510(k)s, IDEs, PMAs, Technical Files and Design Dossiers.
• MDD to MDR Gap Analyses.
• Perform detailed RA Assessment of Change: ECO/DCO/MCO, etc.
• Review and assess changes to the design, manufacturing, and labeling for impact to product approvals/submissions.
• Develop global regulatory strategies for new product introductions as well as existing product changes.
• Global registration guidance and support.
• Act as regulatory representative on product development teams.

What we’re looking for:
• A Bachelor’s degree within a scientific or technical discipline; Master’s degree or RAC Credential.
• 5-7 years of Regulatory Affairs experience specifically within the medical device industry, experience with Class II and Class III devices preferred.
• Extensive knowledge of current and evolving domestic and international regulatory compliance requirements.
• Proficient in technical writing with a relentless attention to detail.
• Flexibility; someone who embraces change because things move quickly around here.
• Strong communicator who actively asks and answers questions.
• As cliché as it sounds, MUST LOVE DOGS.

What we offer:
• Competitive compensation, including 401(k) match, paid vacation and holidays.
• Medical, dental and life insurance.
• Flexible working hours.
• Continued education—tuition reimbursement for career development courses.
• Open office space with lots of natural light centrally located in NE Minneapolis.
• Lunch provided every day.

Fang Consulting is an equal opportunity employer; we welcome diversity and encourage veterans to apply.



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