Senior Director, Regulatory Affairs - Med Devices

elemed; San Diego (TX); On-site; USD 120,000 - 180,000; Full time

Job summary

A leading medical device company is seeking a Director of Regulatory Affairs based in San Diego, CA. The role involves developing regulatory strategies for product submissions, overseeing a regulatory team, and collaborating with internal and external stakeholders to ensure compliance with regulations. Candidates should have significant experience in Regulatory Affairs, preferably within the Medical Device industry, and excellent communication and project management skills.

Qualifications

• Minimum 10 years of relevant work experience in the Medical Device industry.
• At least 5 years of experience managing a regulatory team.
• Experience with external service providers and regulators required.

Responsibilities

• Lead and mentor junior regulatory staff.
• Prepare and file variation and renewal applications for approvals.
• Coordinate interactions between internal stakeholders and external service providers.

Skills

Project management skills

Organizational abilities

Excellent written and verbal communication

Interpersonal skills

Proficiency in Microsoft Office Suite

Education

Bachelor’s degree in Science, Engineering or Business Administration

Master’s degree or higher preferred

Tools

Microsoft Excel

Microsoft PowerPoint

Job description

A leading medical device company is seeking a Director of Regulatory Affairs based in San Diego, CA. The role involves developing regulatory strategies for product submissions, overseeing a regulatory team, and collaborating with internal and external stakeholders to ensure compliance with regulations. Candidates should have significant experience in Regulatory Affairs, preferably within the Medical Device industry, and excellent communication and project management skills.