Regulatory Affairs Associate

Regulatory Affairs Associate

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.

Responsibilities :

• Reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications. Communicates changes to global regions and supports preparation of global notifications as needed.
• Participates in core teams and provides guidance on regulatory requirements to product development teams, with guidance / support from management.
• Supports preparation of dossiers and submission packages for regulatory agencies.
• Supports strategic regulatory activities of a more senior RA team member.
• Reviews advertising and promotional material for respective product line(s) and / or regions(s) as needed.
• Maintains regulatory databases / systems with key regulatory data for respective product line(s) and / or region(s) as needed.
• May participate in regulatory body audits in a supporting role.
• Demonstrates data interpretation skills to provide solutions, draw conclusions and identify trends.
• Completes day-to-day support for RA Systems.
• Ability to travel up to 25% of the time.

Minimum Requirements :

Preferred Requirements :

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.

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.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.