Regulatory Affairs Manager

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.

The Regulatory Affairs Manager will lead and manage regulatory submissions approvals and compliance activities for medical devices . This role ensures that products meet all national and international regulatory requirements facilitating timely market access and maintaining post-market compliance.

Job Responsibilities

• Develop and execute regulatory strategies for new product introductions and product lifecycle management.

• Prepare review and submit regulatory filings (e.g. 510(k) PMA CE Mark etc.) to regulatory agencies worldwide.

• Act as the primary liaison with regulatory agencies during pre-submission meetings reviews and inspections.

• Interpret and apply complex regulatory requirements to product development manufacturing and marketing activities.

• Conduct regulatory assessments for design changes manufacturing changes and labeling updates to determine impact and required submissions.

• Manage and maintain regulatory licenses registrations and approvals.

• Provide regulatory guidance and support to cross-functional teams including R&D Quality Marketing and Clinical Affairs.

• Monitor and analyze evolving global regulatory landscapes assessing potential impacts on products and processes.

• Participate in internal and external audits to ensure compliance with quality system regulations (e.g. ISOCFR Part 820).

• Develop and deliver regulatory training to internal stakeholders.

Required Qualifications

• Bachelors degree in a scientific engineering or related field; advanced degree (Masters or Ph.D.) preferred.

• Minimum of 5-7 years of experience in Regulatory Affairs within the medical device industry.

• Ability to work on-site in Covington GA

Desired Skills and Experience

• Demonstrated success in preparing and obtaining regulatory approvals (e.g. FDA 510(k) PMA CE Mark).

• In-depth knowledge of global medical device regulations (e.g. FDA regulations MDD/MDR Health Canada TGA MHLW).

• Strong understanding of quality management systems (e.g. ISOCFR Part 820).

• Excellent written and verbal communication skills with the ability to effectively communicate complex regulatory information.

• Strong analytical and problem-solving abilities with keen attention to detail.

• Ability to work independently and collaboratively in a fast-paced dynamic environment.

• RAC (Regulatory Affairs Certification) preferred.

• Proficiency in Microsoft Office Suite and regulatory submission software.

• Office is located in Covington GA

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 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

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. #CLOLI

For additional details regarding submission eligibility and payment terms please refer to your contract. Only submissions from agencies with current service contracts in place will be considered.