(Sr.) Director, Medical Device Quality

About Aura Biosciences:

Aura Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function. Aura’s lead candidate, bel-sar (AU-011), is currently in late-stage development for early choroidal melanoma and in early-stage development in other ocular oncology indications and bladder cancer. Aura is headquartered in Boston, MA. Aura’s mission is to grow as an innovative global oncology company that positively transforms the lives of patients.

For more information, visit aurabiosciences.com. Follow us on X (formerly Twitter) @AuraBiosciences and visit us on LinkedIn.

Position Summary:
The (Sr.) Director of Medical Device Quality is the senior leader responsible for establishing, scaling, and overseeing Aura’s global quality strategy for medical devices and combination products. This role ensures that all device development, testing, manufacturing, clinical use, and commercial distribution meet the highest standards of safety, compliance, and performance. The (Sr.) Director partners closely with R&D, Device Engineering, Clinical, Regulatory, and Commercial teams to build a world class quality organization that supports Aura’s rapid growth and global regulatory obligations.

Key Responsibilities:
•    Product Development Quality Leadership — Support device teams throughout development, testing, verification, validation, and commercialization of new combination products and modifications to existing products. Ensure quality is embedded across the product lifecycle.
•    Regulatory Submission & Commercialization Support — Partner with Regulatory Affairs to support global submissions and commercial readiness for Aura’s devices and combination products. Ensure quality documentation and processes meet regulatory expectations.
•    Design History File & Design Controls — Create and maintain technical documentation for the combination product Design History File (DHF). Lead and manage design control processes to ensure compliance with 21 CFR Part 4, 21 CFR 820, ISO 13485, and MDR.
•    Regulatory Body Interface — Serve as the primary quality interface with regulatory authorities (US, EU, Australia, etc.). Support audits, prepare responses to third party audit observations, and ensure timely resolution of findings.
•    Training & Clinical Education Leadership — Act as the subject matter expert (SME) to develop and deliver training programs for internal teams, clinical partners, and commercial stakeholders on device and combination product quality requirements.
•    Quality System Development — Build and scale Aura’s Quality Management System (QMS) to meet 21 CFR Part 4, ISO 13485, and EU MDR requirements for combination product development and lifecycle management.
•    Clinical & Post Market Safety Oversight — Create and manage Aura’s clinical trial device safety monitoring program and oversee commercial post market surveillance activities, including complaint handling, risk management, and field safety actions.
•    Manufacturing Quality Oversight — Support manufacturing record review, batch documentation, and quality release of Aura’s combination products. Ensure robust quality oversight of internal and external manufacturing partners.
•    Global Compliance Assurance — Ensure Aura’s device quality systems remain compliant with ISO 13485, 21 CFR Parts 4 and 820, and EU MDR 2017/745. Drive continuous improvement initiatives to maintain audit ready operations.

Qualifications:
•    Bachelor’s or Master’s degree in Engineering, Quality, Regulatory Affairs, or related field; advanced degree preferred
•    12+ years of experience in medical device or combination product quality, with at least 5 years in senior leadership
•    Deep expertise in ISO 13485, 21 CFR Part 820, 21 CFR Part 4, and EU MDR
•    Proven experience supporting regulatory submissions and global audits
•    Strong background in design controls, DHF management, and risk management
•    Experience building and scaling QMS in high growth environments
•    Excellent leadership, communication, and cross functional collaboration skills

Salary & Benefit Information:

Salary Range: $195,000/yr - $295,000/yr

(Placement within the listed range depends on many factors including, but not limited to: geographic location, degree, years of experience, and internal company equity)

Health insurance with FULL premium coverage

401K with company match

Employee Stock Purchase Program (ESPP)

Competitive paid time off (PTO)

Company-paid short & long-term disability insurance and life insurance