Senior Regulatory Affairs Manager - Medical Devices

Planet Pharma; Memphis (TN); On-site; USD 120,000 - 170,000; Full time

Job summary

Planet Pharma is seeking a Manager of Regulatory Affairs to lead the QA/RA functions and ensure ongoing compliance with domestic and international regulations as part of the Quality Management System.

You will coordinate regulatory strategies, support product development, and guide submissions while working with cross-functional teams to address risk, labeling, and adverse events in a fast-paced medical device environment.

Qualifications

• Five to seven years of QA/RA experience with a medical device company or related field.
• Strong knowledge of 21 CFR Part 820 and ISO 13485.
• Experience with regulatory submissions and registrations (e.g., 510(k)).
• Ability to lead cross-functional teams and drive regulatory strategy.

Responsibilities

• Oversee daily QA/RA activities and ensure compliance with applicable regulations.
• Maintain and improve the Quality Management System across functions.
• Lead regulatory submissions strategy and submission readiness for new products.
• Collaborate with product development, manufacturing, and suppliers on risk assessment and control plans.
• Manage labeling, adverse event reporting, and regulatory communications.

Skills

QA/RA leadership

Regulatory compliance

Medical devices experience

Regulatory intelligence

Excellent communication

Job description

Planet Pharma is seeking a Manager of Regulatory Affairs to lead the QA/RA functions and ensure ongoing compliance with domestic and international regulations as part of the Quality Management System.

You will coordinate regulatory strategies, support product development, and guide submissions while working with cross-functional teams to address risk, labeling, and adverse events in a fast-paced medical device environment.