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Regulatory Affairs Consultant
Fang Consulting
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Regulatory Affairs Consultant

Fang Consulting

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Details
Posted:
March 20, 2021
Location:
Roseville, Minnesota
Type:
Full Time - Experienced
Categories:
Medical Device, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
Required Education:
4 Year Degree
Fang Consulting specializes in Medical Device Regulatory Affairs and Quality Consulting; we are headquartered in Minnesota’s Medical Alley and have a global reach of connections and clients.
 
We’re committed to finding an experienced, collaborative Regulatory Affairs 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 and remediation
  • IVDD to IVDR gap analyses and remediation
  • 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 degrees are nice too
  • 2-5 years of Regulatory Affairs experience specifically within the medical device industry, experience with Class II and Class III devices and IVDs strongly preferred
  • Developed working 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 and dental insurance; company-paid LTD, STD, and life insurance
  • Flexible working hours
  • Continued education—tuition reimbursement for career development courses
  • Lunch provided every day 

Internal Number: 1
About Fang Consulting
Fang Consulting is headquartered in Minnesota’s Medical Alley with a widespread, global network of resources and connections. Our team of medical device experts use their extensive knowledge of the most current and ever-evolving US & international regulations to provide comprehensive premarket and postmarket support to our startup and leading medical device clients. Our regulatory and quality teams have the experience to mitigate risks and ensure our clients obtain the clearance to sell both new and existing products in any market with completely customizable onsite and remote support, ranging from regulatory and quality staff augmentation to auditing and project work.
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