Lumicity
Base pay range
$180,000.00/yr - $200,000.00/yr
Position Overview The Director of Quality and Regulatory Affairs will join a rapidly growing, venture‑backed medical device startup at a pivotal stage of development and commercialization. This role will serve as a senior leader responsible for building, scaling, and owning the company’s quality and regulatory infrastructure as products transition from development into broader clinical and commercial use. Reporting into executive leadership, this position blends strategic oversight with hands‑on execution. The Director will act as the central authority for quality and regulatory matters, shaping processes that enable speed, compliance, and long‑term scalability in a startup environment.
Key Responsibilities
Own and continuously evolve the Quality Management System in compliance with FDA regulations and ISO 13485.
Lead design control activities and ensure quality and regulatory requirements are embedded early in product development.
Support regulatory submissions and ongoing interactions with regulatory authorities in the U.S. and internationally.
Serve as the primary representative during FDA inspections, ISO audits, and notified body engagements.
Drive effective CAPA, complaint handling, and post‑market surveillance processes.
Establish and oversee supplier quality programs as manufacturing scales.
Partner closely with Engineering, Operations, Clinical, and Commercial teams to enable efficient, compliant execution.
Build and lead the quality and regulatory function, providing structure, mentorship, and accountability as the organization grows.
Required Qualifications
10+ years of experience across Quality Assurance and/or Regulatory Affairs within the medical device industry.
Experience supporting regulated medical devices, ideally Class II or higher.
Strong working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971.
Experience supporting U.S. regulatory submissions (e.g., 510(k)) and product lifecycle management.
Direct involvement in FDA inspections, ISO audits, or regulatory assessments.
Hands‑on experience with design controls, risk management, CAPA, and post‑market activities.
Proven ability to operate effectively in fast‑paced, rapidly scaling organizations and lead cross‑functional initiatives.
Preferred Qualifications
Prior experience in early‑stage or high‑growth medical device startups.
Exposure to international regulatory pathways (EU MDR, Health Canada, etc.).
RAC certification or advanced technical degree.
Why This Role This is a rare opportunity to take ownership of quality and regulatory strategy within a rapidly expanding startup, where decisions made today will directly shape the company’s trajectory, culture, and ability to scale responsibly. The role is ideal for a leader who thrives in ambiguity, values accountability, and wants to build durable systems that support innovation while protecting patients. Impact, visibility, and long‑term growth are central to this position.
Seniority level Director
Employment type Full‑time
Job function Quality Assurance
Benefits
Medical insurance
Vision insurance
401(k)
Disability insurance
#J-18808-Ljbffr
Position Overview The Director of Quality and Regulatory Affairs will join a rapidly growing, venture‑backed medical device startup at a pivotal stage of development and commercialization. This role will serve as a senior leader responsible for building, scaling, and owning the company’s quality and regulatory infrastructure as products transition from development into broader clinical and commercial use. Reporting into executive leadership, this position blends strategic oversight with hands‑on execution. The Director will act as the central authority for quality and regulatory matters, shaping processes that enable speed, compliance, and long‑term scalability in a startup environment.
Key Responsibilities
Own and continuously evolve the Quality Management System in compliance with FDA regulations and ISO 13485.
Lead design control activities and ensure quality and regulatory requirements are embedded early in product development.
Support regulatory submissions and ongoing interactions with regulatory authorities in the U.S. and internationally.
Serve as the primary representative during FDA inspections, ISO audits, and notified body engagements.
Drive effective CAPA, complaint handling, and post‑market surveillance processes.
Establish and oversee supplier quality programs as manufacturing scales.
Partner closely with Engineering, Operations, Clinical, and Commercial teams to enable efficient, compliant execution.
Build and lead the quality and regulatory function, providing structure, mentorship, and accountability as the organization grows.
Required Qualifications
10+ years of experience across Quality Assurance and/or Regulatory Affairs within the medical device industry.
Experience supporting regulated medical devices, ideally Class II or higher.
Strong working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971.
Experience supporting U.S. regulatory submissions (e.g., 510(k)) and product lifecycle management.
Direct involvement in FDA inspections, ISO audits, or regulatory assessments.
Hands‑on experience with design controls, risk management, CAPA, and post‑market activities.
Proven ability to operate effectively in fast‑paced, rapidly scaling organizations and lead cross‑functional initiatives.
Preferred Qualifications
Prior experience in early‑stage or high‑growth medical device startups.
Exposure to international regulatory pathways (EU MDR, Health Canada, etc.).
RAC certification or advanced technical degree.
Why This Role This is a rare opportunity to take ownership of quality and regulatory strategy within a rapidly expanding startup, where decisions made today will directly shape the company’s trajectory, culture, and ability to scale responsibly. The role is ideal for a leader who thrives in ambiguity, values accountability, and wants to build durable systems that support innovation while protecting patients. Impact, visibility, and long‑term growth are central to this position.
Seniority level Director
Employment type Full‑time
Job function Quality Assurance
Benefits
Medical insurance
Vision insurance
401(k)
Disability insurance
#J-18808-Ljbffr