Staff Regulatory Affairs Specialist (Hybrid) at Becton Dickinson NA in Franklin Lakes, New Jersey

Job Description:

Job Description Summary

Staff Regulatory Affairs specialist supporting medication delivery and vascular care products within the BD Medication Delivery Solutions business unit. Responsible for activities to support product regulatory approvals in global markets.



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 Summary:

The Staff RA Specialist will provide regulatory support to the BD Plymouth site for all aspects of product registration including but not limited to, preparation of documentation required for registration, monitoring of ongoing compliance and acting as the primary contact for any issues arising with Notified Bodies or other authorities. The role holder will also be responsible for supporting the business in maintaining appropriate records relating to Quality Management Systems (QMS) and regulatory matters.



Responsibilities:

• Support new product development by providing advice on labelling requirements and conducting regulatory risk assessments


• Ensure that products are registered with relevant authorities prior to commercialisation


• Monitor the regulatory environment and respond to changes which may affect the site or its products


• Maintain accurate and up-to-date records relating to QMS and regulatory matters


• Respond to enquiries from customers/distributors regarding registrations


• Work closely with manufacturing operations to ensure compliant manufacturing processes


• Assess the impact of product or process changes on registrations


• Apply knowledge of regulations to provide guidance to the business


• Represent the site at regulatory inspections


• Attend meetings with Notified Bodies and other authorities as necessary


• Review promotional material to ensure it is compliant with advertising codes


• Support audits and inspections

Qualifications:

• Bachelor's degree or equivalent experience in Science, Engineering, or related discipline


• 5 years experience working within a Registration Department or similar role preferred


• Knowledge of medical device regulations such as EU Medical Device Directive, IVDD, MDR, ISO14971, etc


• Ability to communicate effectively both verbally and in writing


• Proficient computer skills


• Excellent interpersonal skills


• Strong attention to detail


• Self-motivated and able to work independently


• Excellent organisational skills


• Good planning and problem solving 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 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.


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Primary Work Location

USA NJ - Franklin Lakes



Additional Locations

USA UT - Salt Lake City



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