Job Description Summary

The Staff Post Market Quality Specialist is responsible for working with MMS on various post market quality issues. This position develops, implements, and/or coordinates global regulatory programs and projects and compliance initiatives across regions, business units, and manufacturing sites.

Job Description

We are the makers of possible 

 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. 

 

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. 

Responsibilities

Post Market Quality activities as it pertains to MMS Business Unit, including:

• Staff Specialists fulfill the role of Field Action Manager (FAM) throughout the entire Field Action Execution process.

• Responsible for end-to-end Field action execution activities including but not limited to participation at situation analysis meetings, documenting regulatory rationales for “no action taken”, agency reporting, customer letter development, communication with all regions, coordination with 3rd party recall contractor, responding to customer questions on field actions and monitoring of trends.

• Input to the Compliance Profile Report, as well as Management Review.

• Supervising Adverse event reporting as well as the processes and procedures

• Acts as a correspondent with US FDA, Health Canada, and other regulators / notified bodies on related matters as appropriate.

• Participates in the development, review and issuance of BD policies and procedures related to Post Market Quality.

• Supports Quality Systems with Regulatory inspections

• Facilitates documentation of segment or corporate audit program

• Participates in the development, review and issuance of policies and procedures related to regulatory compliance.

• Provides training for compliance and/or quality system activities as required.

• This position may have no direct reports, however must accomplish tasks through mentor and collaboration with other Regulatory, Quality, Medical, Operations, and R&D professionals worldwide.

Education and Experience

• BA or BS degree, with 5-7 years related experience in the medical device or pharmaceutical industry.

• Working knowledge of 21 CFR820, ISO 13485, ISO 14971 and other international standards as required

• Certifications in Regulatory Affairs/Compliance desirable

Knowledge

• Working knowledge of 21 CFR820, 21CFR806, ISO 13485, Health Canada recall regulations and other international standards as required

Skills

• Proficiency in Microsoft Office, specifically Word and Excel

• Must be able to work optimally with cross-functional teams

• Excellent written and oral communication skills

• Strong Organization & Prioritization Skills

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.  

To find purpose