Senior Regulatory Affairs Specialist

Abbott   •  

Saint Paul, MN

Industry: Healthcare

  •  

5 - 7 years

Posted 182 days ago

This job is no longer available.

JOB DESCRIPTION:

**Position can be based out of Westford, MA or Minnesota**

We are seeking an experienced, high caliber Senior Regulatory Affairs Specialist. This position leads the preparation and submission for regulatory approvals and acts independently to identify and resolve problems. Provides regulatory guidance to cross-functional partners and demonstrates strategic thinking and creativity in support of programs.  Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.    

Job Duties: 

  • Prepares robust regulatory applications to achieve departmental and organizational objectives
  • Creates, reviews and approves engineering change orders
  • Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team
  • Provides guidance and expertise
  • Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail
  • Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems
  • Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations - Interfaces directly with FDA and other regulatory agencies
  • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release
  • Conducts reviews of product and manufacturing changes for compliance with applicable regulations - Reviews protocols and reports to support regulatory submissions

Qualifications:

  • BA or BS degree; technical discipline preferred
  • A minimum of 5 years of technical experience, including at least 4 years of regulatory experience in a medical device industry
  • Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions
  • Experience with Software and capital equipment a plus
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Ability to travel approximately 15%
  • Experience working in a broader enterprise/cross-division business unit model preferred 

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