BD (Becton, Dickinson and Company) Regulatory Affairs Specialist in New Hope, Minnesota

Category: Regulatory Affairs Specialist

Job ID: 2018-11499

Career Level: experienced

Division: New Hope, MN / Lutonix

Relocation: Relocation Not Available

Location: New Hope,Minnesota,United States

Summary of Position with General Responsibilities:

This individual in this position will be responsible for global adverse event reporting, world-wide regulatory submissions and ensuring compliance with all the required regulations for assigned projects.

Essential job Functions:

Responsibilities:

  1. Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develop, document and implement regulatory submission plans around product development/line extension goals.

  2. Prepares U.S. FDA submissions (e.g., IDE, PMA) as required and per applicable SOPs.

  3. Prepares and updates European and International technical files/dossiers/registrations as required and per applicable SOPs.

  4. Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and International regulations and standards.

  5. Ensures adequate documentation of Bard Lutonix compliance to FDA, European and International regulations and standards. Ensure Regulatory Affairs files are updated and maintained as required.

  6. Develops working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Bard Lutonix notified body.

Basic Qualifications:

Qualifications:

  • Minimum of 2 years Regulatory Affairs medical industry or related industry experience (medical device, pharmaceutical and/or healthcare)

  • Experience with regulatory oversight and filing of reportable pre- and post-market adverse events and vigilance reports a plus

  • Bachelors of Science or technical degree preferred

  • Excellent written and oral communication and technical writing skills

  • Strong organizational and interpersonal skills

  • Ability to effectively manage multiple projects with shifting priorities

  • General knowledge of FDA and European medical device regulations, including IDE, PMA, & MDD

  • Able to apply independent decision making and analytical thinking skills

  • Proficiency with PC computer and Microsoft Office software

  • Technical knowledge of interventional vascular devices, related medical procedures and associated medical terminology preferred

  • Ability to work independently with minimal supervision

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status