Regulatory Affairs Manager - PHCS

The ideal candidate will bring a strong background in FDA submissions, regulatory strategy, and cross-functional leadership within the medical device, biotechnology, pharmaceutical, or in-vitro diagnostics industries. Collaborate with cross-functional teams including R&D, Quality, Clinical Affairs, Manufacturing, and Program Management to ensure regulatory requirements are integrated into business processes.

Regulatory Affairs Manager – Software & Instrumentation (PHCS)
Location:1910 East Innovation Park Drive, Tucson, AZ 85755
Pay Rate: $45–$55/hour
Contract: 1 year, with potential for extension and/or permanent placement

About the Role

We are seeking an experienced Regulatory Affairs Manager to support Software and Hardware products within Personalized Healthcare Solutions (PHCS). This role is responsible for developing and executing regulatory strategies, securing and maintaining global product approvals, and ensuring compliance throughout the product lifecycle. The ideal candidate will bring a strong background in FDA submissions, regulatory strategy, and cross-functional leadership within the medical device, biotechnology, pharmaceutical, or in-vitro diagnostics industries.

Key Responsibilities

• Lead the preparation and submission of complex regulatory dossiers and registration packages for software and instrumentation products.
• Develop and implement global regulatory strategies to support product development, commercialization, and lifecycle management activities.
• Manage regulatory compliance throughout the product lifecycle, including change controls, product modifications, and maintenance of market authorizations.
• Collaborate with cross-functional teams including R&D, Quality, Clinical Affairs, Manufacturing, and Program Management to ensure regulatory requirements are integrated into business processes.
• Anticipate regulatory risks and proactively develop solutions to support timely product approvals and market access.
• Interpret and apply global regulatory requirements, health authority guidance, and industry standards to support strategic decision-making.
• Represent Regulatory Affairs during audits, inspections, and interactions with regulatory agencies and external stakeholders.
• Build strong partnerships across global teams and effectively navigate complex stakeholder environments.
• Mentor and support junior team members while fostering a culture of collaboration, innovation, and continuous improvement.
• Drive adoption of new technologies, tools, and processes that enhance regulatory efficiency and data stewardship.

Required Qualifications

• PhD with 3–5 years of experience, OR
• Master's degree with 5–7 years of experience, OR
• Bachelor's degree with 6–8 years of experience in Regulatory Affairs within the IVD, Medical Device, Biotechnology, Pharmaceutical, or Biopharmaceutical industry.
• Previous experience supporting FDA submissions for software and/or instrumentation products.
• Demonstrated ability to manage highly complex projects and influence cross-functional stakeholders.
• Strong knowledge of regulatory submission processes, compliance requirements, and product lifecycle management.
• Exceptional communication, stakeholder management, negotiation, and conflict-resolution skills.
• Proven analytical, strategic thinking, and problem-solving abilities.

Preferred Qualifications:

• Experience supporting global regulatory submissions and approvals.
• Knowledge of regulatory requirements in Europe, China, and other international markets.
• Familiarity with international quality standards and regulatory frameworks.
• Experience with Software as a Medical Device (SaMD), diagnostic instrumentation, digital health technologies, or companion diagnostics.
• Strategic mindset with the ability to translate regulatory requirements into practical business solutions.
• Strong leadership capabilities and the ability to influence without direct authority.
• Ability to make sound decisions in ambiguous and fast-paced environments.
• Excellent written and verbal communication skills.
• Passion for advancing innovative healthcare technologies that improve patient outcomes.

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