Job Description Summary
We are seeking a highly motivated individual to join our team as a Regulatory Affairs (RA) Specialist responsible for supporting the regulatory compliance of medical devices in the EMEA and LATAM regions. In this role, you will have the opportunity to make a difference in people's lives through innovative technology. You will work on various projects related to new product registrations, license renewals, market access strategies, and other RA activities across the EMEA and LATAM regions. Associates will be expected to work in the Franklin Lakes office Monday through Thursday and work from home on Fridays.
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
- Support the registration of medical devices in multiple countries within the EMEA and LATAM regions by preparing documentation for local authority review.
- Monitor changes in regulations and ensure compliance with all relevant laws and guidelines.
- Collaborate with cross-functional teams such as marketing, quality assurance, and engineering to ensure timely submission of applications and smooth approval processes.
- Develop and implement effective strategies for obtaining approvals in a timely manner while minimizing costs and risks.
- Maintain accurate records of all regulatory submissions and correspondence with regulators.
- Stay up-to-date with emerging trends in the field of medical device regulation and advocate for policies that promote patient safety and access to innovative technologies.
- Provide guidance and support to internal stakeholders regarding regulatory requirements and compliance issues.
About You
- Bachelor’s degree or equivalent education/experience preferred.
- Minimum 2 years of relevant work experience with at least one year of international regulatory affairs experience required preferably in the medical device industry.
- Strong understanding of regulatory frameworks governing medical devices in the EMEA and LATAM region.
- Excellent communication skills with ability to collaborate effectively across different departments and levels of management.
- Ability to manage multiple priorities simultaneously while meeting tight deadlines.
- Proven problem solving abilities and attention to detail.
- Knowledge of ISO standards related to medical devices.
- Experience working with international organizations is advantageous.
- Proficiency in Microsoft Office Suite including Word, Excel, PowerPoint, Outlook, etc.
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
Optional Skills
Primary Work Location
USA NJ - Franklin Lakes
Additional Locations
Work Shift
