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Senior Regulatory Affairs Specialist IV

Location : Chaska, MN
Hours : Full Time
Travel : No
Relocation : No

Job Description :

Our client’s contribution to healthcare is offering a range of diagnostic solutions, clinical data management tools and process management expertise.  Their goal is to provide solutions improving healthcare around the globe.




Our client has an opportunity for a Senior Regulatory Affairs Specialist IV.  In this role they are looking for a high-level strategist, individual contributor and subject-matter-expert responsible for creating and executing regulatory strategies for pre- and post-market activities as well as the ability to manage complex issues that may have significant impact on the business.



  • Collaborative facilitator, building consensus while championing global regulatory initiatives for projects.

  • Provide pre- and post-market regulatory initiatives for immunoassay devices, ensuring the development and implementation of these advanced and aggressive regulatory strategies provide a competitive edge

  • Author premarket submissions, including 510(k)s and PMA supplements to the U.S. FDA in alignment with pre-market strategies

  • Work through the company’s design controls for product changes to determine when new registrations may be required due to design change

  • Create / Manage Technical Files in compliance with IVDD and IVDR

  • Work with international colleagues on establishing design dossiers for their intended market

  • Collaborate with international Regulatory Affairs professionals to support global product registrations

  • Ensure sound premarket product regulatory strategies include the timely and consistent review of post-market activities, such as adverse events and recall notification, minimizing the risk of negative premarket submission actions, including agency review delays

  • Communicate with regulatory agencies in the US, Canada, the EU and other geographic areas, as required

  • Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively.

  • Utilize Business System tools to drive compliance and effective processes; developing regulatory metrics and scorecards and institute data-based process improvements which will align with corporate and business unit goals.


  


Salary:  $50-53/hr DOE (contract)


Schedule:  M-F 8am – 5pm


Benefits:  Medical and Dental available


 


 


 


Required Qualifications :

 



  • Bachelor’s degree with 9+ years of experience

  • or Master’s degree with 7+ years of regulatory experience, preferably in areas of life sciences, engineering, or quality assurance

  • An advanced scientific degree is strongly preferred


Preferred experience to be successful in this role



  • 15 years of relevant experience in a regulated medical device/diagnostic industry

  • A subject matter expertise in regulatory affairs for medical devices and in vitro diagnostics

  • Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and IVD (in vitro diagnostics)

  • Previous experience in registration and commercialization of medical device and diagnostic products

  • Ability to develop effective regulatory strategies and apply regulations to premarket strategies

  • Ability to possess a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Development

  • Proven leadership and managerial skills in order to build and sustain a vision for the work group

  • Demonstrated track record of developing organizational capability

  • Global experience leading and/or participating on cross functional teams

  • Professional designations (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean) – A Plus!

  • Training and certificates in quality or regulatory affairs - A Plus!


 


 


 

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