Job Description:
Job Description Summary
The RA Coordinator provides administrative and coordination for a variety of Regulatory Affairs activities related to global registrations and functional goals. The RA Coordinator will support multiple Regulatory Affairs professionals across different product lines. The RA Coordinator will be responsible for managing and completing multiple tasks on a daily basis. They will assist members of the RA team to support compliance with global regulatory requirements and ensure project and department deliverables are met. The RA Coordinator will provide administrative support, assistance with tracking metrics and related data, as well as assisting in entry level regulatory affairs related tasks.
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:
- Provide general administrative support for regulatory project management by assisting with tracking project status and maintaining tracking tools.
- Effectively manage multiple competing priorities and work in a fast-paced, regulated environment.
- Coordinate meetings with colleagues at both local and regional levels and check the project status.
- Assist with creation and reporting of department and project related metrics.
- Manage RA Teams sites by organizing meeting content, functional goals, submission & project tracker's, and team information
- Manage State Licenses; annual renewals, audit support as well as supporting external vendor.
- Liaise with the subject matter experts to collect information and communicate with the team members.
- Assist with ordering, notarization, legalization and apostille process for regulatory documentation.
- Collaborate with other project leads to share the project status and metrics.
- Coordinate functional webinars, trainings, team functions by aiding in slide development, planning, and execution.
- Work across full suite of Microsoft office software programs, Adobe, and multiple internal software programs/databases.
Qualifications:
- Bachelor's Degree in a related field.
- Minimum 2-3 years' experience with regulatory affairs or a related field.
- Minimum two-four years' experience in a rapidly changing administrative environment dealing with rapidly changing priorities and timelines. Experience with medical products regulatory or clinical documents is preferred.
Competencies:
- Ability to plan and schedule multiple priorities in a concurrent fashion.
- Ability to review, collate and summarize scientific and technical data.
- Good problem solving and analytical skills.
- Good written and oral communication skills.
- Previous experience in the medical device industry.
- Detail-oriented, methodical and able to handle regulatory information and submissions with a high degree of accuracy.
- Ability to work independently and complete assigned work with minimal supervision.
- Excellent writing and strong organizational skills.
- Previous experience in general administrative support.
- Currently an active notary public or able to become a notary public within Rhode Island.
Key Relationships:
- Internal Relationships: Regulatory Affairs (RA) Staff, Quality Assurance, Field Assurance, Research and Development, Product Management, Manufacturing, Sales, Marketing
- External Relationships: BD Corporate RA and BD RA International Business Centers (IBCs); may also receive communications from customers, sales representatives, external medical, and FDA/Notified Bodies
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 RI - Warwick
Additional Locations
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