Director of Regulatory Affairs

Supporting innovative endoscopy and diagnostics technologies

Onsite/hybrid: Bay Area ( San Jose )

Reports to: Sr. Director RA/QA

This is a unique opportunity to join a growth-stage medical technology company that has pioneered innovative capsule endoscopy technology and is now advancing its platform through AI-driven software, enhanced visualization capabilities, and next-generation diagnostic solutions. With commercial products already on the market and continued investment in product development, the company is entering an exciting phase of growth as it expands its regulatory and product portfolio.

Roles and Responsibilities

Main Activities

• Coordinate and facilitate communication and information flow for premarket regulatory activities.
• Prepare responses to FDA inquiries and requirements.
• Engage with cross-functional teams, including R&D, Quality Assurance, and Clinical Affairs, to gather and integrate relevant data for regulatory submissions.
• Support the implementation of risk control measures and strategies for product development and post-market surveillance.
• Collaborate with stakeholders to identify potential risks, assess their impact, and develop mitigation strategies.
• Ensure regulatory compliance by maintaining knowledge of applicable regulations and standards.
• Assist in the preparation and submission of regulatory documentation and reports.
• Utilize project management skills to plan, execute, and monitor regulatory projects.
• Provide assistance to senior regulatory leadership in addressing internal and external information requests for premarket or postmarket activities.
• Actively engage in process improvement initiatives to streamline and optimize regulatory processes and procedures.
• Work closely with cross-functional teams to identify and escalate any deficiencies to relevant subject matter experts (SMEs).
• Support reviews and approvals of materials intended for regulatory submissions, ensuring compliance with regulations and guidelines.

Additional Activities

• Support Quality Management System activities such as CAPA, customer complaints, and internal audits.
• Participate in internal/external audits and inspections, ensuring procedures, processes, and documentation meet Quality Management System, ISO 13485, and applicable regulatory requirements.
• Support process improvement and implementation of regulatory projects and tools.
• Assist and support other employees, teams, and field personnel as necessary.
• Assist with product recalls and field corrections.
• Perform other regulatory tasks and projects as assigned.

Qualifications

*Bilingual English/Mandrin Prefered

Knowledge

• Comprehensive knowledge of medical device regulatory requirements, including ISO 13485:2016, ISO 14971:2019, and 21 CFR 820.
• Proven project management experience, including planning, execution, and monitoring of projects.
• Strong knowledge of regulatory requirements and risk management principles.
• Proficiency in regulatory affairs software and systems.
• Proven record of successful FDA 510(k) submissions.
• General computer literacy (Microsoft Word, Excel, PowerPoint, Outlook).

Experience

• Minimum of 5 years of Regulatory Affairs experience and 8 years of overall medical device industry experience.
• Bachelor's or Master's degree in medical technology, life sciences, or a related field, or equivalent experience.

Interpersonal Skills

• Strong organizational and planning skills with the ability to manage multiple tasks simultaneously.
• Proactive problem-solving skills and ability to work independently and within a team environment.
• Familiarity with process improvement methodologies and a continuous improvement mindset.
• Strong interpersonal skills and ability to work across departments.
• Excellent communication skills with the ability to interact effectively with diverse stakeholders.
• Detail-oriented with strong analytical skills and attention to regulatory requirements.
• Fluent in written and spoken English.

Preferred Knowledge

• Strong knowledge of FDA 21 CFR 807.
• Working knowledge of FDA 21 CFR 803, 806, and 820.

Benefits

• 401(k)
• Health Insurance
• Dental Insurance
• Vision Insurance
• Paid Time Off

Additional Requirements

• Experience leading FDA 510(k) submissions.
• Minimum 2 years of experience managing FDA questions and interactive reviews.
• Onsite position.