Position title
Regulatory Affairs Specialist
Description

The Regulatory Affairs Specialist works with a team to develop and execute international strategies for regulatory approval of medical device products. The person in this role will work as assigned in these areas:

Responsibilities
  • Coordinates, compiles and submits U.S, and/ or International regulatory submissions, including filing and/or creation of 510Ks, PMAs, IDEs, Premarket Notifications, Supplements, Change Notifications, and other country-specific product registrations.
  • Develop IDE/ 510K/ PMA (US) and Technical Files/ Design Dossiers (EU) submissions for class II and III medical devices.
  • Manages the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products
  • Carries out Post Market Surveillance activities such as CAPA support, post market risk management, recalls, and complaint handling.
  • Supporting basic and advanced market entrance, providing acquisition due diligence, UDIs, and clinical evaluation reporting (CERs).
  • Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
  • Represents department on cross-functional product development and manufacturing support teams. Guide teams to provide content for US and/or International submissions, participates in design reviews as needed.
  • Communicates with and maintain productive, constructive relationships with external customers as required – US FDA, Health Canada, in-country regulatory representatives, and notified-bodies.
  • Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects.
  • Assist in regulatory due diligence for potential and new acquisitions
  • Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams

 

About Company Client:

  • Grew Regulatory and Quality teams by double digits in 2018.
  • Has a retention rate of over 95%.
  • Hiring for direct hire roles, but may consider Contractors also.
  • Offers generous company benefits to include health, dental, and vision insurance, 401K and disability insurance.
Qualifications

Education

  • Bachelors degree, or equivalent of education and experience sufficient to successfully perform the essential Bachelor’s degree required: bio-medical engineering or the life sciences highly preferred.
  • Regulatory Affairs Certification (US or EU) preferred
  • RAPS certification preferred

 

Experience

  • 1-10 years of direct experience in regulatory and/or quality assurance, specific to medical devices.

 

Skills

  • Works with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.
  • Initiative and ability to be self-directed, while thriving in a setting requiring collaboration and teamwork for maximal efficiency and effectiveness
  • Ability to effectively respond to time sensitive issues and meet deadlines
  • Ability to anticipate, quickly address and make correct decisions in a fast-paced, dynamic environment
  • Ability to focus on multiple projects and re-establish priorities as necessary
Employment Type
Full time
Industry
Medical Device
Job Location
REMOTE Based-Anywhere, Minneapolis, MN
Base Salary
$ 70,000 - $ 130,000
Date posted
December 3, 2018
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Position: Regulatory Affairs Specialist

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