Regulatory Affairs Associate
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.
This position holds responsibility for maintaining regulatory department documentation which includes updating, cataloging, archiving and processing department documents. Example documents include: regulatory submissions – 510(k)s, PMAs; 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:
- Aids in the preparation of regulatory documentation for domestic and international product registrations and secures appropriate regulatory documentation.
- Interfaces with domestic and international partners/distributors regarding registrations and licenses.
- Researches and aids in the interpretation of FDA, IVDD/IVDR, etc regulations.
- 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.
- Aids in the evaluation of customer complaints for regulatory compliance and adherence to product claims.
- Plans and participates in internal and external audits as required.
- Travels to audits, industry conferences/meetings or external training events may occur as required.
- Create and support quality initiatives to maintain an environment of continuous improvement throughout the organization.
- Ensures compliance with EDI’s Quality Management System.
- A minimum of scientific degree (BS) is required.
- 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
- Dental Insurance
- Health Insurance
- Paid Time Off
- Vision Insurance
- 8 Hour Shift
- Monday to Friday
- Regulatory Compliance: 1 year (Preferred)
- Bachelor’s (Required)
Learn more here
Job posted: 2020-07-30