BD (Becton, Dickinson and Company) Jobs

Job Information

BD (Becton, Dickinson and Company) Medical Affairs Quality Assessment Professional in Miami, Florida

Job Description Summary

Job Description

This is an assignment position that will begin January 2021 and ends on or before May 31st, 2022.

As a Medical Affairs Quality (MAQ) Assurance Auditor, you are responsible for performing audits in support of Medical Affairs’ processes and procedures to support the new requirements of the EU Medical Device Regulation/ In Vitro Diagnostics Regulations. In addition, you will work with the sites and/or functions to ensure submitted objective evidence is compliant with domestic and international regulations, corporate standards, and local procedures. You will monitor metrics and prepare reports for management.

This role will report to the Medical Affairs Post Market Surveillance and Operations, VP.

In addition, this role will serve as a liaison to other cross-function teams working on EU MDR/IVDR.

This role will also be responsible to seek and build opportunities for efficiency for delivering Medical Affairs processes for EU MDR/IVDR. In addition, this role will serve as a liaison to other cross-function teams working on EU MDR/IVDR.

Primary Responsibilities:

  • Conduct Medical Affairs assessments to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures, specifically compliance to MDR/IVDR

  • Support Medical Affairs during internal/external audits

  • Support of Global Clinical Development (GCD) operational processes, includes but not limited to general operations, safety, vendor management, etc

  • Evaluate the adequacy of the provided evidence against the approved action plans.

  • Provide periodic reports to management

  • Partner with Quality and Regulatory to ensure clear and appropriate alignment of processes for adverse event reporting for EU MDR/IVDR

  • Find opportunities for efficient work practices and continuous improvement that would support the business unit Medical/Clinical EU MDR/IVDR work (i.e. identify and handle vendor for literature searches).

  • Strong knowledge of the global regulatory environment for medical devices and IVDs.

  • Education in a Technical or Medical Science subject area, or other related field, or equivalent work experience

  • Experience collaborating with regulatory bodies including the FDA, European notified bodies.

Your Profile:

  • Education in a Technical or Medical Science subject area, or other related field, or equivalent work experience

  • You have at least 5 years of work experience in an auditing role within the Medical Device and/or Pharmaceutical company.

  • You have a minimum of 3 years’ experience in auditing compliance with domestic and international regulations for medical devices or pharmaceuticals. Experience assessing clinical areas is a plus

  • You have working knowledge and ability to apply international regulations and standards of FDA QSR, ISO 13485, EU MDR/IVDR, and ISO 14971 standards.

  • You have knowledge and experience in CAPA

  • You have excellent verbal and written communication skills in English.

  • You have a consistent track record to successfully collaborate and partner with all levels of management

  • You have strong analytical skills, effective project management, and social skills.

  • One of the following highly preferred certifications or equivalent: Certified Quality Auditor/ISO Lead Auditor Certified, Certified Quality Engineer, or Certified Quality Manager.

  • You are willing to travel domestically and internationally.

  • Deep understanding of the commercial and R&D organizations and how Medical/Clinical spans and supports these organizations.

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.

Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

USA FL - Miami, USA IL - Vernon Hills, USA UT - Salt Lake City

Work Shift

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.

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

DirectEmployers