Staff Regulatory Affairs Specialist Advertising/Labeling (Hybrid)

Job Description Summary

Job Description

We are

the makers of possibleBD 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.

Our generous benefits including but not limited to :

• Competitive salary
• Comprehensive benefits package including retirement savings plan, insurance (health, dental, vision) and more!
• Have a happier, healthier work life with less stress and more time for hobbies and interests by taking advantage of flexible paid time off and paid holidays!
• Relocation assistance may be available

Key responsibilities : Review and approve labels, labeling, and promotional materials to ensure regulatory compliance.

Work closely and collaboratively with Marketing and project teams to develop, review, and substantiate product claims.

Review and evaluate protocols, reports, and journal articles to ensure collection of appropriate data to support promotional materials.

Drive the collection of regulatory intelligence for projects related to US and OUS labeling remediation.

Effectively communicate regulatory strategies to stakeholders.

Problem solve and escalate regulatory and compliance issues to senior management, as necessary.

Keep business partners informed of the status of regulatory owned tasks.

Perform gap analysis to support labeling projects and remediation activities.

Assist in drafting standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.

Remain current on standards and regulations affecting advertising, promotion, and labeling and communicate the impact cross-functionally.

Perform other duties and assignments as required.

Professional Skills & Key CompetenciesExcellent verbal and written communication skills.

Demonstrated ability to analyze, interpret, and review scientific, technical, and regulatory literature and documents while effectively communicating information to peers and management while working independently with minimum supervision.

Excellent attention to details.

Flexible and adaptable to fulfill business priorities.

Computer literacy (SAP, Microsoft Word / Excel / PowerPoint).

Manages time efficiently.

Knowledge of global Regulatory Affairs requirements.

Strong organizational skills

Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.) and work with all levels of management.

Identify and communicate risks and mitigations associated with regulatory strategies to cross-functional collaborators.

Qualifications : Bachelor’s degree in Life Sciences or Engineering.

Advanced degree (e.g. MS, Life Sciences) preferred

Minimum of five (5) years of Regulatory Affairs experience in the medical device and / or pharmaceutical industry preferred.

Strong prioritizing, interpersonal, communication, and analytical skills, and the ability to multi-task disparate projects

Knowledge of global Regulatory Affairs requirements, regulations, and standards

Desired / Additional Skills & Knowledge : Familiarity and background with advertising, promotion, and labeling in the medical device industry.

CertificationsRAPS RAC preferred.

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 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.Required SkillsOptional Skills.Primary Work Location

USA CA - San Diego TC Bldg C&D

Additional Locations

USA NC - Durham - Roche Drive

Work Shift

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.Salary Range Information$121,100.00 - $199,800.00 USD Annual

Salary : $121,100 - $199,800