Senior Regulatory Affairs Manager, Medical Devices

Medella Life; Cambridge (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating with cross-functional teams. The ideal candidate has over 7 years of experience in regulatory affairs, strong knowledge of FDA regulations, and a relevant degree. This position offers a dynamic work environment and the chance to influence product lifecycle management.

Qualifications

• 7+ years of regulatory affairs experience in the medical device industry.
• Demonstrated experience preparing and supporting submissions for Class II medical devices.
• Strong working knowledge of FDA regulations, Quality System Regulation, and ISO 13485.

Responsibilities

• Define and implement regulatory strategies for new product development.
• Manage FDA regulatory submissions for Class II medical devices.
• Partner with various departments to integrate regulatory requirements.

Skills

Regulatory strategy development

FDA regulations knowledge

Collaboration with cross-functional teams

Regulatory submissions preparation

Excellent communication skills

Education

Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related

Job description

A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating with cross-functional teams. The ideal candidate has over 7 years of experience in regulatory affairs, strong knowledge of FDA regulations, and a relevant degree. This position offers a dynamic work environment and the chance to influence product lifecycle management.