Regulatory Affairs Leader - Medical Devices (Onsite GA)

Becton Dickinson; Covington (GA); On-site; USD 130,000 - 190,000; Full time

Job summary

Becton, Dickinson and Company is seeking an experienced Senior Regulatory Affairs professional for onsite work in Covington, GA. You will lead regulatory strategy for medical devices, prepare submissions (510(k), PMA, CE Mark) and interact with authorities.

You will mentor a team, liaise with R&D, Quality, Clinical, and Marketing, and ensure compliance across development and commercialization stages. The role requires 8–10 years in Regulatory Affairs within medical devices, with leadership

Qualifications

• Bachelor's degree in a scientific or technical discipline 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 role.
• Demonstrated expertise in 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 for diverse audiences.
• Proven ability to lead projects and manage multiple priorities in a fast-paced environment.

Responsibilities

• Develop and implement regulatory strategies for new product development and post-market activities.
• Prepare and submit regulatory documents (510(k), PMA, CE Mark, international submissions).
• Act as primary regulatory contact with agencies during submissions, reviews, and inspections.
• Interpret complex regulations to ensure compliance across development and commercialization.
• Lead junior regulatory professionals and foster a culture of compliance.
• Support audits and assess regulatory impact of product and process changes.
• Collaborate with R&D, Quality, Clinical, Marketing to achieve regulatory objectives.
• Monitor regulatory trends and disseminate updates relevant to the portfolio.

Skills

Regulatory leadership

Regulatory submissions

FDA regulations

International registrations

Communication skills

Project management

Regulatory strategy

Education

Bachelor's degree in scientific/technical discipline

MS/PhD preferred

Tools

Regulatory information management systems

Job description

Becton, Dickinson and Company is seeking an experienced Senior Regulatory Affairs professional for onsite work in Covington, GA. You will lead regulatory strategy for medical devices, prepare submissions (510(k), PMA, CE Mark) and interact with authorities.

You will mentor a team, liaise with R&D, Quality, Clinical, and Marketing, and ensure compliance across development and commercialization stages. The role requires 8–10 years in Regulatory Affairs within medical devices, with leadership