Principal Regulatory Affairs Specialist

The Principal Regulatory Affairs Specialist is responsible for the support of new product development and maintenance of business projects.  Specific activities include but are not limited to:

  • Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), Technical Files, and STED
  • Collaborate with internal Cardinal international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution
  • Review design control documents including documents associated with design inputs and design outputs
  • Review product labeling for compliance with global labeling regulations
  • Review advertising and promotional literature for compliance with applicable regulations
  • Interpret and evaluate proposed regulations and advise on impact of such regulations on the business
  • Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies

MINIMUM REQUIREMENTS:

Education:   

  • Bachelor’s Degree in a scientific discipline

Skills/Qualifications:

  • 7+ years Regulatory Affairs Experience or equivalent
  • Majority of Regulatory Affairs experience in Medical Device industry preferred

Competencies:

  • Proficiency in US and Europe medical device regulations
  • Strong organizational skills
  • Ability to manage multiple projects
  • Deadline conscious
  • Problem solving skills
  • Team oriented
  • Strong oral and written communication skills

Other skills:

  • Fluent in local language required

OTHER REQUIREMENTS:

  • Travel time required, up to 5%

    WORKING CONDITIONS:

  • General office environment