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Sr. Regulatory Affairs Specialist

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Location
MN
Job Type
Direct Hire
Date
Nov 14, 2018
Job ID
2624666

 Our client, a small clinical trial stage company is adding a Sr. Regulatory Affairs Specialist to their team.  The Specialist will engage in planning and execution of global regulatory activities necessary to support implementation of clinical trials and subsequent commercial distribution of companies products. This position will provide regulatory functional representation and review of documentation related to clinical trials, labeling, design and specification, and manufacturing processes, as applicable to area of responsibility and according to US and international regulations, standards, and guidance.  Willing to consider RA candidates with only 510k or post-market RA experience and train them on IDE submissions!

Your role with the company:

  • Exercise creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks
  • Provide hands-on regulatory affairs support for new product investigation/marketing approvals for new and existing products, including development of regulatory requirements/strategies and preparation of submissions
  • Perform regulatory submission/approval activities for complex  products
  • Represent company in interactions with US and international regulators on submission reviews/approvals and ensure compliance with required regulations and established corporate standards
  • Define worldwide regulatory requirements necessary for (clinical trial and commercial) regulatory approval of products
  • Complete regulatory assessments and strategies as required to support assigned projects and provide direction to project teams to support new product development and product modifications as required
  • Provide direction on application of external standards for assigned projects as required
  • Execute product submission strategies as directed.
  • Maintain all regulatory documentation to ensure availability for audits and preparation of submission packages
  • Rigorous documentation for all phases of regulatory submissions, including priority setting, requirements research, documentation gathering, submission writing, approvals, renewals, and change orders
  • Understand and communicate current and evolving regulatory submission requirements for clinical trial and commercial distribution of medical devices in the US, Canada, and Europe

Desired Profile:
 

  • BS degree in Science or Engineering or a combination of education and experience providing equivalent knowledge
  •  5 years medical device industry experience
  • Minimum of 3 plus years of experience in Regulatory Affairs, including FDA, Health Canada, and/or EU submissions/approvals
  • Working knowledge and experience with EU, FDA, and Health Canada regulations and guidelines
  • Through understanding of FDA and international submission requirements including how to comply with standards and regulations
  • Strong technical writing skills
Preferred:
  • 5 plus years working in Regulatory Affairs
  • IDE submission experience
  • Demonstrated ability in project management skills to plan, conduct and implement system assessments and robust submissions
  • High level of planning and organizational skills