This position works closely with direct supervision to learn and develop the regulatory skills required to bring medical devices to market and ensure ongoing compliance. This position is part of the Regulatory Affairs Compliance team, responsible to ensure local regulatory procedures adhere to government regulations, industry standards, and corporate policies; support internal and external audits; monitor regulatory systems for completeness and accuracy; and support other regulatory compliance activities, as needed.
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.
Job Responsibilities:
Collaborates with Regulatory Affairs, Quality Assurance, and other associates on compliance support activities
Understands fundamental global regulatory and quality system requirements
Stays informed of new regulations and changes to existing regulations and communicates to management
Monitors and analyzes regulatory information systems data; and coordinates actions to address issues
Verifies product regulatory information to be submitted to global external databases
Provides subject matter expertise on regulatory information systems to Regulatory Affairs team
Provides regulatory support for internal and external quality system audits
Supports development and implementation of corrective action plans for regulatory compliance findings
Maintains FDA device listings and establishment registrations
Writes and updates standard operating procedures (SOP), work instructions (WI), and policies and conducts internal training , as needed.
Conducts gap assessments of new and revised corporate procedures and external regulations and standards, and updates local documents accordingly
Coordinates and responds to requests for product data and information
Supports regulatory business processes
Provides regulatory support for implementation of new systems and processes
Qualifications:
Bachelor's degree or higher, preferably in a scientific discipline
0-2 years' experience; prior experience (including internships) in the medical device industry preferred (preferably in Regulatory Affairs or Quality)
Preferred Skills:
Excellent written and verbal communication skills
Excellent problem solving and analytical skills
Detail-oriented, with a focus on accuracy and completeness
Excellent organization skills: able to manage multiple tasks and meet timeline commitments
Ability to work in a team-oriented, fast-paced environment
Desire to develop knowledge of global medical device regulations, with a focus on US and EU requirements
Desire to develop knowledge of ISO 13485 and 21 CFR 820 quality system requirements
Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint)
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 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.
Required Skills FDA Medical Device Regulations, Medical Device Regulations, Regulatory Compliance Optional Skills
Global Regulatory, Regulatory Affairs Compliance, Regulatory Processes, Standard Operating Procedure (SOP) .
