The Opportunity:

Universal DX is seeking an experienced Senior Manager/Associate Director of Software Development Compliance to join our growing team. You will work directly with the Sr. Director of Production Engineering and will play an integral role in contributing towards the Company’s future growth by leading and ensuring that the next generation of Universal DX’s medical device software are carried out in accordance with IEC 62304, ISO 14971, ISO 13485, and FDA 21 CFR 820.30.

The role ensures that planning, requirements management, architecture and design documentation, implementation controls, risk management, verification, release, and postmarket feedback are executed in a traceable and audit-ready manner. The Associate Director also ensures the software lifecycle integrates with broader QMS elements, cybersecurity expectations, and system-level risk controls, and that development activities withstand notified-body and FDA scrutiny.

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

How you’ll contribute:

· Define and maintain a compliant IEC 62304 software development lifecycle integrated with ISO 13485 QMS process.

· Align software development artifacts and evidence with FDA 21 CFR 820.30 design controls and objective evidence expectations.

· Serve as the process owner for software lifecycle documentation, covering requirements, traceability, verification, risk management and related quality records.

· Ensure requirements and traceability activities are performed in alignment with IEC 62304.

· Ensure verification and validation activities are performed in alignment with IEC 62304, FDA guidance on General Principles of Software Validation (2002), and Computer Software Assurance (2025).

· Ensure risk management activities are performed in accordance with ISO 14971.

· Ensure risk controls are implemented, verified, and traceable from hazards through mitigation and residual risk-justification.

· Ensure development activities and records are inspection-ready for FDA, notified-body, and MDSAP audits.

· Contribute to the creation of regulatory submission and technical files (e.g., design history evidence, SDLC documentation summaries, risk traceability, verification evidence, cybersecurity controls)

· Ensure emerging FDA cybersecurity requirements (e.g., secure development practices) are incorporated into product development activities.

· Ensure post-market surveillance and complaint data feeds back into the development lifecycle for software changes (e.g., CAPA, ECR).

· Monitor for relevant changes in the regulatory environment and proactively lead process improvements.

· Provide leadership, coaching, and performance development for the requirements and verification teams to ensure consistent understanding of regulatory obligations.

· Mentor verification and requirements managers and ensure alignment of strategy, capacity planning, and competence development.

What you’ll bring:

· At least 8+ years of experience in software development compliance in a regulated medical device or diagnostics environment.

· Deep working knowledge of IEC 62304, ISO14971, ISO 13485, and FDA 21 CFR 820.30.

· Proven track record leading requirements engineering and software verification functions in a regulated setting.

· Experience implementing or governing compliant SDLC frameworks and design controls, ensuring alignment with relevant regulatory guidelines.

· Experience submitting Class II and III regulatory applications, ideally for IVD software products or similar PMA-focused items.

· Experience responding to inquiries from FDA throughout a PMA submission, especially for software, risk management, or cybersecurity portions of a regulatory submission.

· Experience supporting or participating in FDA inspections for PMA or DeNovo submissions, including presenting lifecycle evidence, risk controls, or verification traceability.

· Experience collaborating with software developers, automation engineers, bioinformaticians, R&D team members, and/or Q&A team members.