Associate Director, Regulatory Affairs - BD Nogales Norte : Job Details

Overview

Associate Director, Regulatory Affairs at BD Nogales Norte. This role leads Regulatory Affairs team members involved in device project activities and new product development within the Advanced Drug Development Delivery platform. The primary US FDA contact, responsible for regulatory activities for the new product portfolio and for deploying standards related to new product design. Onsite required in Franklin Lakes, NJ, Monday through Thursday; option to work from home on Friday.

Primary Responsibilities

• Lead RA team members, balancing support with empowerment and coaching to drive cultural change and position RA as solution providers.
• Own regulatory strategy to ensure all Pharmaceutical Systems products meet current requirements for successful new product developments.
• Own promotional material review activities and business procedures; ensure external communications and claims align with regulatory requirements.
• Educate and train cross-functional teams on EU and FDA requirements applicable to pharmaceutical systems and customers, to maintain ongoing regulatory understanding.
• Maintain appropriate registrations with Competent Authorities, develop response strategies for regulatory questions, and prepare the team to interact with regulatory agencies when necessary.

About You / Qualifications

• Bachelor's degree in a technical field required (engineering, biology, chemistry, pharmacy); advanced degree preferred; medical training preferred.
• Minimum 8 years in regulatory affairs within pharmaceutical or medical device industries, ideally with drug-device combination products; experience in regulatory and/or R&D, quality engineering, design control, product development, and multiple submission dossiers with regulatory authorities.
• Demonstrated supervisory and leadership skills; ability to drive change and inspire associates.
• Ability to navigate a matrix environment and build relationships enabling RA as a business partner and respected voice.
• Comprehensive knowledge of U.S. medical device regulations (FDA), Clinical Practice standards, Laboratory Practice regulations, and Quality System Regulations.

Salary & Benefits

Salary range: $177,700 - $293,100 USD annually. Salary ranges vary by location and role; final offer based on experience, education, skills, and work location. On-site collaboration is emphasized; minimum 4 days in-office per week for most roles. Remote or field-based roles will have different arrangements as indicated in the posting.

Location

USA NJ - Franklin Lakes

About BD

BD is a global medical technology company advancing health. We are committed to equal opportunity employment. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic status, sexual orientation, gender identity or expression, disability, military status, or other legally protected characteristics.

Why Join Us?

Join a team that values your opinions and contributions, supports learning and growth, and strives to make a difference in health. Explore the possibilities at BD and discover a culture where you can thrive.