Associate Director, Regulatory Affairs - Medical Devices

kozmetickesluzby.vecnakraska.sk - Jobboard; San Diego (CA); Hybrid; USD 130,000 - 180,000; Full time

Job summary

kozmetickesluzby.vecnakraska.sk - Jobboard is seeking an Associate Director of Regulatory Affairs to provide regulatory support for medical device systems at our San Diego site. This role involves developing regulatory strategies for new product submissions and handling existing registrations.

The ideal candidate will have over 10 years of experience in the Medical Device industry and at least 5 years in Regulatory Affairs. The position offers a flexible work schedule with opportunity for remote work on Fridays.

Qualifications

• Minimum 10 years of relevant work experience in the Medical Device industry.
• Minimum 5 years in Regulatory Affairs with complex medical device systems and software.
• Experience working with external service providers, consultants, and regulators.

Responsibilities

• Provide regulatory support for medical device systems.
• Develop and implement regulatory strategies for new product submissions.
• Handle existing product registrations and compliance documentation.
• Coordinate interactions between internal and external stakeholders.
• Directly interface with regulators as needed.

Skills

Project management skills

Organizational abilities

Written communication skills

Verbal communication skills

Proficient in Microsoft Office Suite

Interpersonal skills

Problem-solving abilities

Team player

Education

Bachelor’s degree in a scientific discipline

Advanced degree

Regulatory Affairs Certification (RAC)

Project Management Certification

Tools

Microsoft Office Suite

Job description

kozmetickesluzby.vecnakraska.sk - Jobboard is seeking an Associate Director of Regulatory Affairs to provide regulatory support for medical device systems at our San Diego site. This role involves developing regulatory strategies for new product submissions and handling existing registrations.

The ideal candidate will have over 10 years of experience in the Medical Device industry and at least 5 years in Regulatory Affairs. The position offers a flexible work schedule with opportunity for remote work on Fridays.