Senior Regulatory Affairs Leader, Medical Devices (Onsite)

Becton Dickinson NA; Covington (GA); Vor Ort; USD 120.000 - 180.000; Vollzeit

Zusammenfassung

Becton, Dickinson, and Company in Covington, GA, onsite, seeks a senior Regulatory Affairs leader to own regulatory strategy across development, lifecycle, and post-market activities. You will submit 510(k)/PMA/CE registrations and serve as primary regulatory contact with authorities.

The role requires 8–10 years in medical devices with leadership exposure, strong cross-functional collaboration, and a proven ability to drive compliant programs in a fast-paced environment.

Qualifikationen

• Bachelor's degree in a scientific or technical discipline (e.g., Biomedical Engineering, Chemistry, Biology) required.
• Advanced degree (MS, PhD) preferred.
• 8-10 years of Regulatory Affairs experience in the medical device industry, with at least 3-5 years in a leadership role.
• Experience preparing and submitting 510(k), PMA, CE Mark, and international registrations.
• Strong knowledge of FDA regulations (21 CFR Parts 800s), ISO 13485, EU MDR, and other international requirements.
• Excellent written and verbal communication skills.
• Proven ability to lead projects and manage multiple priorities.

Aufgaben

• Develop and implement regulatory strategies for product development, lifecycle management, and post-market activities.
• Prepare, review, and submit regulatory documents (510(k)s, PMA, CE Mark, international submissions).
• Act as primary regulatory contact with agencies during submissions, reviews and inspections.
• Interpret and apply complex regulations to ensure product compliance.
• Lead and mentor junior regulatory professionals.
• Participate in internal and external audits.
• Assess regulatory impact of product, manufacturing, and quality system changes.
• Collaborate with R&D, Quality, Clinical, Marketing to achieve regulatory objectives.
• Monitor regulatory changes and industry trends relevant to the portfolio.

Kenntnisse

Regulatory strategy

510(k) submissions

PMA submissions

CE Marking

Regulatory communications

Team leadership

Regulatory information management

Ausbildung

Bachelor's degree in a scientific/technical discipline

MS or PhD preferred

Tools

Regulatory information management systems

Jobbeschreibung

Becton, Dickinson, and Company in Covington, GA, onsite, seeks a senior Regulatory Affairs leader to own regulatory strategy across development, lifecycle, and post-market activities. You will submit 510(k)/PMA/CE registrations and serve as primary regulatory contact with authorities.

The role requires 8–10 years in medical devices with leadership exposure, strong cross-functional collaboration, and a proven ability to drive compliant programs in a fast-paced environment.