Senior Medical Device Regulatory Lead

Rhythmlink; Columbia (SC); On-site; USD 105,000 - 120,000; Full time

Job summary

Rhythmlink in Columbia, SC is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for new product development and lifecycle management, including cross-functional collaboration with engineering, quality, and clinical teams.

You will develop EU MDR technical documentation, manage 510(k) submissions, and monitor global regulatory requirements to maintain market authorizations and ensure audit-ready records.

Qualifications

• Bachelor’s degree in engineering, biomedical science, life science, regulatory affairs, or related field.
• At least 7 years of progressive regulatory affairs experience in the medical device industry.
• Experience authoring or maintaining EU MDR 2017/745 technical documentation.
• Experience supporting regulatory submissions and market authorizations.

Responsibilities

• Lead regulatory activities for new product development and lifecycle projects.
• Develop and maintain EU MDR 2017/745 technical documentation.
• Support 510(k) submissions and international registrations.
• Advise cross-functional teams on regulatory requirements and strategies.
• Prepare audit responses and regulatory submissions evidence.

Skills

Regulatory affairs

Technical writing

Cross-functional leadership

Regulatory strategy

Quality systems

Education

Bachelor’s degree in engineering or life sciences

Associate degree in related field

Job description

Rhythmlink in Columbia, SC is seeking a Senior Regulatory Affairs Specialist to lead regulatory activities for new product development and lifecycle management, including cross-functional collaboration with engineering, quality, and clinical teams.

You will develop EU MDR technical documentation, manage 510(k) submissions, and monitor global regulatory requirements to maintain market authorizations and ensure audit-ready records.