Regulatory Associate III/IV | Astute Medical, Inc.

JOB TITLE: Regulatory Associate III/IV

DEPARTMENT: Regulatory Affairs

REPORTS TO: Vice President Clinical & Regulatory Strategy

Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the commercialization of its novel biomarker products, Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Regulatory Associate.

JOB SUMMARY:

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • 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.

KNOWLEDGE/SKILLS/ABILITIES 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.

PHYSICAL DEMANDS:

While performing the duties the employee is:

  • Constantly required to reach computers and other office equipment
  • Constantly required to view objects at close and distant ranges
  • Frequently required to communicate with others
  • Frequently required to sit
  • Frequently required to stand
  • Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
  • Frequently required to lift and transport items weighing up to 25 lbs.
  • May occasionally be required to travel to audits, meetings, tradeshows

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

WORK ENVIRONMENT:

Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Workweeks exceeding 40 hours are required as necessary.

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