Astute Medical, Inc.
3550 General Atomics Ct, Building 2, San Diego, CA 92121
Regulatory Associate III/IV
General Job Description:
This position will work as part of the Regulatory Department with direct responsibility for maintaining regulatory department documentation which includes updating, cataloging, archiving and processing department documents (e.g., regulatory submissions – 510(k)s, PMAs; technical files; etc; permits and licenses; regulations, guidance documents, and quality system procedures; post-market, adverse event/recall documentation; publications/bibliographies – clinical/scientific literature, periodicals; 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, permits and licenses which may include responsibilities for compiling documents for medical device applications/technical files, public notary, etc. Assists in processing of change control documents, including advertising and promotional materials, package inserts, box labels, training materials, etc. Participates on internal/external project teams (i.e. design control, change control, CAPA, complaints) involving regulatory review, approval and feedback. May participate in internal/external audits. May interact with regulatory agencies with respect to facility inspections, licensures and permits. 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.
Aids in the preparation of regulatory documentation for domestic and international product registrations and secures appropriate regulatory documentation including device licenses, device listings, permits and import/export certificates.
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 product/project 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, documentation and relevant clinical/scientific literature are maintained and periodically updated as required to maintain a state of audit/inspection-readiness
Generates/revises documentation and data necessary for department operations (e.g., SOPs, forms, tables, records, reports, meeting summaries, etc.)
Advises/acts on implications of new or amended standards relevant to medical devices manufactured by Astute Medical.
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.
Ensure compliance with Company’s Quality Management System and ensure that all individuals reporting to him/her comply with the Company’s Quality Management System.
A minimum of scientific degree (BS) and experience in IVD regulatory affairs typically acquired through 3-5 years relevant industry experience; or equivalent plus knowledge the length of which is dependent on the level of qualifications achieved.
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 state, federal (e.g., 21 CFR 820) and international procedures (e.g., IVDR, ISO 13485, ISO 14971) relevant to the registration/clearance/approval and post-market surveillance of IVDs.
Ability to work cohesively with multi-disciplinary scientific working groups.
Good organization, interpersonal and judgment skills to influence many diverse internal/external customer groups.
Proficient with Microsoft Office suite.
Application Information & Contact (How to Apply)
Please apply through their career page here.
Learn more about Astute Medical here.