Global Regulatory Manager, Medical Devices (Aesthetics)

EPM Scientific; Bothell (WA); On-site; USD 100,000 - 130,000; Full time

Job summary

A global diversified pharmaceutical company is seeking a Manager of Regulatory Affairs. This role involves developing regulatory strategies for medical devices with a focus on aesthetics. The ideal candidate will have a Bachelor's degree in life sciences and a minimum of 6 years' experience in regulatory affairs within a multinational medical device context. Responsibilities include preparing regulatory documentation, leading compliance efforts, and collaborating with cross-functional teams. This is an opportunity to significantly shape the future of healthcare.

Qualifications

• Minimum of 6 years' experience in regulatory affairs within a multinational medical device company.
• Deep understanding of international regulations for active medical devices.
• Proven experience preparing and submitting 510(k)s and Health Canada applications.

Responsibilities

• Develop and implement global regulatory strategies for medical device products.
• Lead the creation of regulatory plans and risk assessments.
• Prepare and submit regulatory documentation such as 510(k)s and EU MDR Technical Files.

Skills

Regulatory strategy development

Cross-functional collaboration

Stakeholder management

Regulatory inspections support

Education

Bachelor's degree in life sciences or a technical discipline

Advanced degree

Job description

A global diversified pharmaceutical company is seeking a Manager of Regulatory Affairs. This role involves developing regulatory strategies for medical devices with a focus on aesthetics. The ideal candidate will have a Bachelor's degree in life sciences and a minimum of 6 years' experience in regulatory affairs within a multinational medical device context. Responsibilities include preparing regulatory documentation, leading compliance efforts, and collaborating with cross-functional teams. This is an opportunity to significantly shape the future of healthcare.