Strategic Regulatory Affairs Leader – Invasive Medical Devices

Maven Research; Irvine (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading medical device company is seeking a Director of Regulatory Affairs to lead regulatory strategy and submissions for invasive electromechanical devices. The ideal candidate will have over 10 years of regulatory experience, especially with 510(k) notifications and EU MDR compliance. This role requires exceptional leadership, analytical problem-solving skills, and the ability to collaborate effectively across departments. The position may involve travel up to 25% domestically and internationally, aligning regulatory strategies with corporate objectives.

Qualifications

• 10+ years of regulatory affairs experience in the medical device industry.
• In-depth knowledge of regulatory requirements for invasive electromechanical devices.
• Strong analytical and decision-making skills.

Responsibilities

• Lead preparation and submission of 510(k) and EU MDR.
• Develop global regulatory strategies for invasive devices.
• Provide regulatory guidance on design controls and risk management.

Skills

Regulatory strategy development

FDA interactions

Regulatory compliance

Problem-solving

Leadership

Communication skills

Education

B.S. in Regulatory Affairs, Life Sciences, Engineering, or related field

Job description

A leading medical device company is seeking a Director of Regulatory Affairs to lead regulatory strategy and submissions for invasive electromechanical devices. The ideal candidate will have over 10 years of regulatory experience, especially with 510(k) notifications and EU MDR compliance. This role requires exceptional leadership, analytical problem-solving skills, and the ability to collaborate effectively across departments. The position may involve travel up to 25% domestically and internationally, aligning regulatory strategies with corporate objectives.