Faites partie de quelque chose de plus grand chez BD. Ici, vous nous aiderez à maintenir nos normes élevées d'un point de vue réglementaire à tous les niveaux, avec un accent particulier sur les soumissions. Cela exige une attention aiguë aux détails, d'excellentes compétences en communication et une passion pour continuer à apprendre et à mettre à jour vos connaissances, ce que nous vous aiderons à faire avec des opportunités d'apprentissage régulières. Ici, vous utiliserez vos connaissances approfondies des réglementations et des exigences de la FDA, du Canada et de l'ISO/MDD entourant les dispositifs médicaux pour atteindre finalement un objectif unique : faire progresser le monde de la santé™. Chez BD, vous pouvez faire une véritable différence d'une personne.
-
Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
As Staff Specialist Post Market Quality, you will Staff fulfill the role of Field Action Manager (FAM) throughout the entire Field Action Execution process. You will be responsible for end-to-end Field action execution activities including but not limited to participation at situation analysis meetings, documentation of regulatory rationales for “no action taken”, agency reporting, customer letter development, communication with all regions, coordination with 3rd party recall contractors, and responding for customer questions on field actions and monitoring of trends.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.
Primary Responsibilities:
Inputs the Compliance Profile and Management Review report
Monitors adverse event reporting as well as processes and procedures
Acts as a correspondent with US FDA, Health Canada, and other regulators and notified bodies on related matters
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 programs
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
Coaches and collaborates with other Regulatory, Quality, Medical, Operations, and R&D professionals worldwide
About You:
Minimum BA or BS degree, with 5-7 years related experience in the medical device or pharmaceutical industry
Certifications in Regulatory Affairs/Compliance desirable
Proficiency in Microsoft Office, specifically Word and Excel
Must be able to work effectively across BD units, regions, and manufacturing sites
Strong Organization & Prioritization Skills
Excellent written and oral communication skills
Working knowledge of 21 CFR820, ISO 13485, ISO 14971 and other international standards as required
Salary ranges have been implemented to reward associates fairly and competitively, as well as tosupport recognition of associates’ progress, ranging from entry level to experts in their field, andtalent mobility. There are many factors, such as location, that contribute to the range displayed. Thesalary offered to a successful candidate is based on experience, education, skills, and actual worklocation. Salary ranges may vary for Field-based and Remote roles. 121,100.00 - 199,800.00 USD Annual
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 in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
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 CA - San Diego Bldg A&BAdditional Locations
USA AZ - Tempe BPV Building 1, USA AZ - Tempe BPV Building 2, USA AZ - Tempe BPV Building 4, USA AZ - Tempe Headquarters, USA CA - San Diego (BDB), USA CA - San Diego (IDS), USA CA - San Diego - Otay Mesa, USA CA - San Diego - Road to the Cure, USA CA - San Diego TC Bldg C&D, USA CA - San Jose (Reagents), USA CA - San Jose - Montecito, USA CA TemeculaWork Shift
NA (United States of America)At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.
Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.
Salary Range Information
$121,100.00 - $199,800.00 USD AnnualSuccess Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.