Mar 07, 2019

REGULATORY AFFAIRS SPECIALIST I

  • Abbott
  • Plymouth, MN, USA
Full time Pharmaceutical

Job Description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.

 JOB DUTIES:

  • Assists in the preparation of regulatory applications (including annual reports, PMA and IDE supplements, 510(k)s, significant change notifications, etc.) to achieve departmental and organizational objectives.
  • Creates, reviews and approves engineering changes.
  • Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines.
  • Reviews and evaluates communications to ensure convey all necessary detail is conveyed and adheres to applicable regulatory standards, including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
  • Maintains knowledge of pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current and up-to-date. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel, if requested. Ensures submissions and communications with regulatory agencies are entered into regulatory submission data base and file systems.   
  • Supports the product release process by reviewing and approving requests for product release.
  • May interface directly with FDA and other regulatory agencies if so directed.
  • Reviews protocols and reports to support regulatory submissions.
  • Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, international regulations, and other regulatory requirements, company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.

QUALIFICATIONS

  • BA or BS degree (degree in a technical discipline preferred).
  • Some experience with medical device industry preferred.
  • Experience working in a broader enterprise/cross-division business unit model preferred.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail. 
  • Job Breakdown

    Job Breakdown

  • 30916427

  • CAHF Cardiac Arrhythmias & Heart Failure

  • Plymouth, Minnesota, United States of America

  • United States - Minnesota - St. Paul

  • Yes, 10 % of the Time

  • Not Applicable

  • Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

    Keyboard use (greater or equal to 50% of the workday)


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