Regulatory Affairs Associate

About:

Epitope Diagnostics, Inc. is an ISO 13845 certified medical device manufacturing company located in Mira Mesa. We specialize in the development and manufacture of immunoassays for the global medical device and diagnostics industry. Our areas of expertise include gastrointestinal, cardiovascular, infectious and autoimmune disease, as well as tumors/cancers and calcium/bone metabolism. We're a small, private company focused on quality products and innovation.

JOB SUMMARY:

This position holds responsibility for maintaining regulatory department documentation which includes updating, cataloging, archiving and processing department documents. Example documents include: regulatory submissions – CE IVDR and US FDA 510(k) for medical device; technical files; etc; regulations, guidance documents, and quality system procedures; post-market, adverse event/recall documentation; publications/bibliographies – clinical/scientific literature, communications; product registration matrix; department training, etc.). The successful candidate will assist in the preparation and maintenance of documentation for international and domestic product registrations, compiling documents for medical device applications/technical files, public notary, etc. Assists in processing of change control documents. Participates in internal/external audits and interact with regulatory agencies with respect to facility inspections. Ensures regulatory compliance with QSR (21 CFR Part 820), ISO13485, IVDD/IVDR, corporate policies/procedures and other state, federal and worldwide regulatory requirements as appropriate.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Write product technical files based on CE IVDR, US FDA510(k) and worldwide product registration requirements. Ensure product technical files are maintained and periodically updated as required.
• Generate or revise documentation necessary for department operation.
• Work with product/project teams on compiling risk assessment.
• Support QA/RA department to maintain an environment of continuous improvement throughout the company.
• Prepare for regulatory documentation to meet domestic and international product registration requirements.
• Responsible for preparation of regulatory documentation for domestic and international product registrations and secures appropriate regulatory documentation.
• Interacts with manufacturing teams to provide regulatory guidance with respect to product development and change control processes and may be responsible for the preparation and review of associated deliverables.
• Works with product/project teams on compiling risk assessment.
• Ensures product technical files are maintained and periodically updated as required to maintain a state of audit/inspection-readiness.
• Generates/revises documentation and data necessary for department operations.
• Support quality initiatives to maintain an environment of continuous improvement throughout the organization.
• Ensures compliance with EDI’s Quality Management System.
• Other tasks may be assigned

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

• Experience in IVD Regulatory Affairs with a minimum of 2 years of relevant industry experience.
• Professional writing skills and effective communication skills
• Basic knowledge of relevant Quality System Standards (21 CFR Part 820, ISO 13485, etc.) in an IVD/Medical Device manufacturing environment.
• General working knowledge of current and evolving international procedures (e.g., IVDR, ISO 13485, ISO 14971) relevant to the registration/clearance/approval and post-market surveillance of IVD products.
• Good organization, interpersonal and judgment skills.
• Proficient with Microsoft Office suite.

Job Type: Full-time

Pay: $62,000.00 - $82,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• FDA regulations: 1 year (Preferred)

Work Location: In person