Job Number: 20019809

Location: Mansfield, MA

Date Posted: 9-2-2017

Job Title: Principal Regulatory Affairs Specialist

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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:

  • 3-5 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

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.


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