Job Title: Regulatory Affairs Associate/Regulatory Affairs Manager

Salary: Negotiable | Start Date: ASAP | Contact: Brooke McCutchan

Job Description:

Arete Biosciences (Arete) is a cutting-edge consulting firm that is built from a team of scientists, strategic thinkers, problem solvers, engineers, and innovators, passionate about creating a positive impact on global health. We have been responsible for the design, development, and management of molecular diagnostic systems, molecular assays, start-ups, and build-ups of several companies. We pride ourselves on developing a vast network of in-house and in-network consultants that collectively can solve any problem presented to us.

We are building out our team with a preference for the Austin, TX area to respond to existing and future projects in IVD reagent and instrument device design, development, and regulatory agency submissions. We are looking for a Regulatory Affairs Associate/Regulatory Affairs Manager to provide regulatory expertise to our clients, draft a variety of submissions (Pre-EUA, EUA, Q-Sub, 510k, PMA, Technical Files, etc.) and interface with/respond to inquiries from the Agency on behalf of our clients. A technical background would be helpful and experience in Point of Care/CLIA Waiver devices and knowledge of companion diagnostics (CDx) and molecular is a plus.

Your day-to-day responsibilities would include but not be limited to:

  • Maintain current knowledge of relevant regulations, standards, and guidance documents

  • Regulatory review of promotional marketing materials, press releases, labeling, etc. for clients to ensure that global regulatory agency requirements are met

  • Participate in the development of clinical trial protocols for clients

  • Liaise and negotiate with global regulatory authorities on behalf of clients

  • Provide advice about regulations to clients for new and/or changed products

  • Coordinate successful submissions and approval of all applications

  • Assist clients in creating technical files, risk management plans and reports, and clinical evaluations

  • Review all global regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards

  • Monitor FDA communications, including Town Hall Meetings, emerging trends regarding industry regulations to determine potential impacts on clients

Education and Experience:

  • BA/BS in life sciences or Clinical Laboratory Scientist.

  • Must have a minimum of 3-5 years Regulatory Affairs experience in In vitro diagnostics or Medical Devices – this experience must include 510(k).

  • RAC certification is a plus.

  • Must be well versed in the aspects of regulatory strategy creation, design control, and cGMP/Quality Systems.

  • Experience as an RA representative on project core teams providing regulatory guidance and RA strategies.

  • Experience in the balance and application of regulatory requirements and ability to explain the pros and cons to clients.

  • Direct and positive experience in communicating with Regulatory Authorities.

  • Outstanding written and oral communication skills, with ability to influence others and negotiate successful outcomes

  • Strong analytical skill and technical/ scientific competence.

  • Attention to details and ability to appropriately assess risks and formulate risk-management strategies.

Benefits include:

  • Competitive Salary

  • Full Medical for all full-time employees and 50% for all dependents

  • 401K plan with 5% match

  • Flexible unlimited vacation

  • Potential for great growth, including on-the-job training and continuing education opportunities

Arete is excited to expand our team and bring on a great individual that is committed to improving healthcare access and quality. We are a young, rapidly growing company—this is a unique opportunity to get in on the ground floor of a company with an extremely bright future.

Arete is an equal opportunity employer and is committed to a diverse workforce.