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Featured Employers
Senior Regulatory Affairs Specialist
Company: Cardinal Health
Location: , NH
Employment Type: Full Time
Date Posted: 05/05/2021
Expire Date: 07/18/2021
Job Categories: Advertising/Marketing/Public Relations, Healthcare, Practitioner and Technician, Installation, Maintenance, and Repair, Manufacturing and Production, Executive Management, Research & Development, Medical
Job Description
Senior Regulatory Affairs Specialist

Cardinal Health is seeking a Senior Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate will provide regulatory support on a range of medical devices. Job responsibilities include support of change development projects, new product development, change assessment, domestic submissions, international submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Medical Solutions business.

The Senior 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:

  • Under direction of manager, support new and modified product development projects to establish and integrate regulatory strategy into project activities.
  • Lead, under direction of manager, the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs.
  • 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
  • Under direction of manager, interpret and evaluate proposed regulations for medical devices and advise on impact of such regulations to the business
  • Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies
  • Maintain and provide regulatory information in support of customer queries, bid and tender submission, customs queries, etc.
  • Assists in the development, maintenance and implementation of regulatory procedures and SOPs

MINIMUM REQUIREMENTS:

Education:

  • Bachelors Degree, in a scientific discipline preferred.

Skills/Qualifications:

  • 1-3 years Regulatory Affairs Experience or equivalent
  • Majority of Regulatory Affairs experience in Medical Device industry preferred
  • Experience with US Class III (PMA) submissions, Amendments, Annual Reports and MAFs is 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 REQUIREMENTS:

  • Travel time required, up to 5%

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

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