Senior Manager Regulatory Affairs

Job Title

Develop and implement comprehensive regulatory strategies for new product development, product life cycle management, and post-market surveillance activities.

Prepare, review, and submit regulatory documents, including 510(k)s, Dossiers, Technical Files, and other international submissions to global health authorities.

Act as the primary regulatory contact for assigned projects, communicating directly with regulatory agencies during submissions, reviews, and inspections.

Interpret and apply complex regulations, guidance documents, and industry standards to ensure product compliance throughout the development and commercialization process.

Lead and mentor junior regulatory affairs professionals, fostering a culture of compliance and continuous improvement.

Participate in internal and external audits, providing regulatory expertise and support.

Assess the regulatory impact of product changes, manufacturing changes, and quality system changes.

Collaborate effectively with R&D, Quality, Clinical, Marketing, and other relevant departments to achieve regulatory objectives.

Monitor and disseminate information regarding new or changing regulatory requirements and industry trends relevant to the company's product portfolio.

Bachelor's degree in a scientific or technical discipline (e.g., Biomedical Engineering, Chemistry, Biology) required. Advanced degree (MS, PhD) preferred.

Minimum of 8-10 years of experience in Regulatory Affairs within the medical device industry, with at least 3-5 years in a leadership or senior role.

Demonstrated expertise in preparing and submitting various regulatory applications (e.g., 510(k), PMA, CE Mark, International registrations).

Strong knowledge of FDA regulations (21 CFR Parts 800s), ISO 13485, Medical Device Regulation (EU MDR), and other relevant international regulatory requirements.

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

Proven ability to lead projects, manage multiple priorities, and work effectively in a fast-paced environment.

RAC (Regulatory Affairs Certification) preferred.

Proficiency in regulatory information management systems and tools.

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.

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.