Regulatory Affairs Associate
About The Position
The Regulatory Affairs (RA) Associate is an entry-level role for the RA Professional. The Associate will provide regulatory support for one or more product lines and/or region(s), including participation on new product development teams and continued support through the lifecycle of the product. The Associate may also help to prepare regulatory submissions required to market new or modified medical devices in global markets. The Associate is able to communicate regulatory issues to management to ensure the business is aware of opportunities, risks and concerns. This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future. 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.
Requirements
- Degree level qualification; or equivalent combination of education and experience.
- Ability to plan and schedule multiple priorities in a concurrent fashion.
- Ability to review, collate and summarize scientific and technical data.
Nice To Haves
- Detail-oriented, methodical and able to handle project work with a high degree of accuracy.
- Ability to work independently and complete assigned work with minimal supervision.
- Good problem solving and analytical skills.
- Excellent writing and strong organizational skills.
Responsibilities
- Reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark requirements. Prepares resulting notifications and communicates changes to global regions while supporting the preparation of global notifications as needed.
- Participates in core teams and provides guidance on regulatory requirements to product development teams with management support. Also supports strategic regulatory activities of more senior RA team members and may participate in regulatory body audits in a supporting role.
- Supports preparation of dossiers and submission packages for regulatory agencies. Reviews advertising and promotional material for respective product lines and/or regions as needed to ensure compliance with applicable regulations.
- Maintains regulatory databases/systems with key regulatory data for assigned product lines and/or regions. Demonstrates data interpretation skills to provide solutions, draw conclusions, and identify trends while completing day-to-day support for RA Systems.
- Demonstrates ability to travel up to 25% of the time to support regulatory affairs functions across different locations as required.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Industry
Miscellaneous Manufacturing
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
