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Regulatory Affairs Associate

Apply Now Job ID R-334567 Date posted 04/04/2019

Job Description Summary

The Regulatory Affairs Associate (RAA) demonstrates ability to create and communicate global regulatory requirements throughout the product lifecycle, working closely with a cross functional team and supervisor. The RAA is able to interpret and communicate regulatory changes to ensure the business is aware of opportunities, risks and issues. The RAA is responsible for ensuring compliance with the regulations and BDPI’s processes and procedures. The RAA utilizes project planning skills to initiate, plan, and execute regulatory projects and submissions with support of supervisor. The RAA manages change and is flexible when providing solutions. The RAA demonstrates collaboration with their regulatory team, cross functional team members, and regulatory agency partners by building strong and effective working relationships. (Support Needle In Project)

Job Description

  • Understands and has working knowledge of FDA medical device regulations, European Medical Device Regulations, and/or other global regulations.
  • Participates in product core teams as required to ensure that the product is in compliance with all internal and external regulatory requirements.  Develops, documents and implements a regulatory strategy plan around product development goals.
  • Initiates and updates regulatory registrations as required and per applicable SOPs.
  • Reviews and approves change orders for compliance with FDA, European and/or global regulations and standards.
  • Provides general support for regulatory team and projects, as needed.
  • Assists in the preparation of division procedures to ensure compliance with Regulatory and Corporate requirements.
  • Ensures adequate documentation of BDPI’s compliance to FDA, European and global regulations and standards.  Ensures maintenance of the Regulatory Affairs files.
  • Performs on special projects as required.
  • Excellent communication (both verbal and written skills).
  • Proven computer skills (Microsoft Word, Excel, PowerPoint, Project, Outlook).
  • Demonstrated problem-solving and analytical skills.
  • Ability to plan and schedule multiple priorities in a concurrent fashion.
  • Ability to review, collate and summarize scientific and technical data.
  • Detail-oriented and critical thinker.
  • Solid project management skills.
  • Experience working with others in a team environment.
  • Bachelor’s degree or advanced degree in technical area such as biology, chemistry, engineering or medical-related field. 
  • Minimum years of experience: 2 years
  • Physical Demands: While performing the duties of this job, the employee is regularly required to stand, walk, sit and use hands to manipulate, handle or feel objects, tools, controls and office equipment.  The employee frequently is required to talk and hear. The employee is occasionally required to reach with hands and arms and stoop, kneel or crouch. 
  • Work Environment: BDPI is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce. While performing the duties of this job, the employee may be in an open cubicle environment. Candidate must be able to work in a team-oriented, fast-paced environment.

Primary Work Location

USA AZ - Tempe BPV Building 3

Additional Locations

Work Shift

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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, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com