Senior Regulatory Affairs Leader, Global MedTech Compliance

BD; Covington (GA); On-site; USD 180,000 - 240,000; Full time

Job summary

BD in Covington, GA is seeking an experienced Regulatory Affairs leader to develop and execute regulatory strategies for medical device development, lifecycle, and post-market activities. You will serve as primary regulatory contact on projects and mentor junior staff.

The role requires 8–10 years in regulatory affairs, strong knowledge of FDA/ISO regulations, and proven leadership. You will collaborate with R&D, Quality, Clinical, and Marketing to achieve compliance and timely submissions.

Qualifications

• 8–10 years of Regulatory Affairs experience in medical devices.
• 3–5 years in a leadership or senior role.
• Experience preparing and submitting 510(k), PMA, CE Mark submissions.
• Strong knowledge of FDA regulations (21 CFR Parts 800s), ISO 13485, EU MDR, and other international requirements.

Responsibilities

• Develop and implement regulatory strategies for new product development, lifecycle management, and post-market surveillance.
• Prepare, review, and submit regulatory documents to global health authorities (510(k), PMA, CE Mark, etc.).
• Act as primary regulatory contact for assigned projects with agencies during submissions, reviews, and inspections.
• Collaborate with R&D, Quality, Clinical, and Marketing to achieve regulatory objectives.
• Monitor regulatory requirements and industry trends relevant to the product portfolio.

Skills

Communication skills

Leadership

Regulatory knowledge

Education

Bachelor's degree in a scientific or technical discipline

Advanced degree (MS, PhD) preferred

Tools

Regulatory information management systems

Job description

BD in Covington, GA is seeking an experienced Regulatory Affairs leader to develop and execute regulatory strategies for medical device development, lifecycle, and post-market activities. You will serve as primary regulatory contact on projects and mentor junior staff.

The role requires 8–10 years in regulatory affairs, strong knowledge of FDA/ISO regulations, and proven leadership. You will collaborate with R&D, Quality, Clinical, and Marketing to achieve compliance and timely submissions.