Position Details

REGULATORY AFFAIRS SPECIALIST

Regulatory Affairs Specialist
Direct Hire
Salary is DOE; ~90-100k
San Diego, CA 92123 (Mission Valley)

Required Skills/Experience:
• Regulatory/Quality experience in the medical device field
• Experience with Medical Device Software and Hardware
• Strong knowledge and application of 21 CFR 820, ISO 13485, EU MDR/MDD, IEC 62304, etc.
• Ability to lead regulatory projects
• Bachelor’s Degree in Science, Engineering, etc.

Soft Skills:
• Excellent verbal and written communication skills, ability to communicate and work at all levels of the organization
• Strong technical writing skills
• Ability to work well with external and internal customers with regulatory requests
• Ability to work in a flexible, dynamic work environment

Summary / Responsibilities:
Prepare, submit, and track regulatory documents and submissions. Ensure submissions are complete, timely, and regulatory objectives are met. Research scientific and regulatory information in order to write, edit, and review reports. Work with various governmental and regulatory bodies (e.g., FDA, MHRA, EMA) to ensure compliance and expedite approval of pending registration. Compile all material required for submissions, license renewals, and annual registrations. Identify relevant guidance documents and interpret international/consensus standards. Participate in internal or external audits and inspections.
• Support/organize/write regulatory submission for new products (including software as medical devices (SaMD) and product changes as required ensuring timely approval for market release and in accordance with applicable regulations, standards and guidance.
• Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals within the company and sector.
• Generate/support the creation of technical files, essential requirements and declaration of conformity and as needed work with Authorized Representative (EU) on country notifications and registrations.
• Participate as the regulatory representative on project teams and new product launches to provide guidance and direction on regulatory requirements.
• Provide guidance and review of product labeling, promotional material, change control and other related product documentation as needed.
• Assist with internal audits and audits from external regulatory bodies.
• Support maintenance of the company's Medical Device Listing and Device Establishment registration forms.
• Recommend modification to internal guidelines, work instructions, and procedures. Draft Regulatory procedures and support updates to other Quality System procedures as needed.
• Support cross functional sites and other business (as applicable) with regulatory needs
• Lead Regulatory Projects as needed

Company / Benefits:
• We provide real-time remote heart monitoring and analysis using our own innovative hardware and software products
• 1000 Employees Globally
• Public since 2000
• Medical, Dental, Vision
• HSA and FSA
• Life, AD&D, and disability
• 401k
• Employee Stock Purchase Plan (ESPP)
• Employee Assistance Program (EAP)
• Vacation, Sick, and Holidays


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