Regulatory Affairs Manager - PHCS - 30522

Regulatory Affairs Manager

Location: Tucson, AZ
Employment Type: 1 year - W2 -Contract
Pay Range: $45–$55/hr

Role Overview

BEPC is seeking an experienced Regulatory Affairs Manager to support software and hardware products within Personalized Healthcare Solutions (PHCS). This onsite position is ideal for a regulatory professional with strong experience in medical devices, in-vitro diagnostics (IVDs), biotechnology, or biopharmaceutical products, particularly those involving software or instrumentation.

In this role, you will be responsible for securing and maintaining regulatory approvals throughout the product lifecycle. You will develop global regulatory strategies, lead complex submissions, navigate evolving health authority requirements, and collaborate with cross-functional stakeholders to support innovative healthcare technologies.

Key Responsibilities

• Regulatory Submissions & Compliance: Lead the development of complex regulatory registration dossiers and global submission plans for software and instrument products.
• Product Lifecycle Management: Maintain regulatory compliance throughout the product lifecycle, including management of product changes and change-control activities.
• Regulatory Strategy: Develop and implement regulatory strategies designed to support efficient global approvals while anticipating potential regulatory challenges.
• Health Authority Requirements: Interpret FDA and international regulatory expectations and translate requirements into actionable strategies for cross-functional teams.
• Risk Management: Proactively identify regulatory risks, evaluate potential impacts, and develop practical, cost-effective solutions.
• Stakeholder Management: Build strong relationships with internal and external stakeholders and effectively navigate competing priorities and complex regulatory issues.
• Audit & External Engagement: Support audit preparation and participate in interactions with regulatory authorities and other external partners as appropriate.
• Decision-Making: Exercise sound judgment when addressing complex or high-impact regulatory matters, including situations where information may be incomplete.
• Leadership & Mentorship: Support an inclusive, collaborative environment while mentoring junior team members and promoting strong regulatory practices.
• Technology & Data Stewardship: Champion effective data stewardship and support adoption of technologies and processes that improve regulatory productivity.
• Communication & Conflict Resolution: Clearly communicate complex regulatory concepts, facilitate productive discussions, and resolve conflicts with transparency and professionalism.

Qualifications

Required:

• PhD with 3–5 years, Master's degree with 5–7 years, or Bachelor's degree with 6–8 years of relevant experience in IVDs, medical devices, pharmaceuticals, or biopharmaceuticals.
• Significant professional experience in Regulatory Affairs or an equivalent regulatory function.
• Previous regulatory experience supporting FDA submissions for software or instrumentation within the medical device, biotechnology, or in-vitro diagnostics industry.
• Demonstrated ability to manage highly complex regulatory work and/or global projects.
• Exceptional stakeholder management and interpersonal skills.
• Strong written and verbal communication abilities, including the ability to clearly communicate complex regulatory concepts.
• Demonstrated ability to navigate conflict, influence stakeholders, and support effective cross-functional decision-making.

Preferred:

• Knowledge of regulatory requirements in the United States, European Union, China, and other international markets.
• Demonstrated ability to interpret and implement applicable regulatory and quality standards.
• Experience developing global regulatory strategies for software-enabled medical devices, instrumentation, or related healthcare technologies.
• Experience working across multidisciplinary and geographically distributed teams.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management.

At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive. With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

Apply Now!

If you are an experienced Regulatory Affairs professional with expertise in FDA submissions, medical device software or instrumentation, and global regulatory strategy, we encourage you to apply.

Please submit an up-to-date resume that includes specific examples demonstrating how your experience meets the qualifications for this position. In particular, clearly highlight your experience with FDA submissions, software and/or instrumentation, global regulatory projects, and relevant IVD, medical device, biotechnology, pharmaceutical, or biopharmaceutical products.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing top-tier consulting and staffing solutions across industries like technology, engineering, manufacturing, and project management. At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive.

With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.