Regulatory Strategy Lead - Medical Devices

Lumicity; San Diego (CA); On-site; USD 250,000 - 350,000; Full time

Job summary

Lumicity is seeking a Senior Director, Regulatory Affairs to lead regulatory strategy for our portfolio of Class II medical devices. This role will drive FDA submissions, labeling, and post-market activities across the product lifecycle.

You will partner closely with R&D, Quality, Clinical, Operations, and Commercial teams to ensure timely and compliant development and market access. International experience is a plus; RAC certification preferred.

Qualifications

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or related field.
• 10+ years of progressive regulatory affairs experience in the medical device industry (Class II).
• Proven track record leading FDA 510(k) submissions from strategy to clearance.
• Strong knowledge of FDA medical device regulations, guidance, and standards.
• Experience with global regulatory pathways and product lifecycle management.

Responsibilities

• Develop regulatory strategies for Class II devices across the product lifecycle.
• Lead preparation and submission of 510(k) and other FDA submissions.
• Regulatory leadership throughout design inputs, reviews, verification/validation, labeling, and transfer.
• Monitor FDA regulations and guidance; advise on impact to products and operations.
• Partner with R&D, Quality, Clinical, Manufacturing, and Commercial teams to ensure compliance and market access.

Skills

Regulatory strategy

FDA regulations

FDA submissions

Cross-functional leadership

Education

Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or related field

Job description

Lumicity is seeking a Senior Director, Regulatory Affairs to lead regulatory strategy for our portfolio of Class II medical devices. This role will drive FDA submissions, labeling, and post-market activities across the product lifecycle.

You will partner closely with R&D, Quality, Clinical, Operations, and Commercial teams to ensure timely and compliant development and market access. International experience is a plus; RAC certification preferred.