Job Details
Posted 2 September, 2026
Job Id: 630606
Regulatory Affairs Manager – PHCS
Job Description
Role Overview
As a key member of the Regulatory Affairs team, you will secure and maintain regulatory approvals for software and instrument products within your area of responsibility. You will drive success through strategic cross-functional collaboration, efficient lifecycle management, and a commitment to innovation and strong leadership principles.
Key Responsibilities
- Submission & Compliance: Oversee the development of complex registration dossiers and global submission plans. Manage the full product lifecycle, ensuring compliance through robust change controls.
- Regulatory Strategy: Develop innovative strategies to accelerate global approvals. Anticipate regulatory hurdles, interpret health authority expectations, and navigate complex, high-stakes issues.
- Stakeholder & External Engagement: Build influential relationships with internal and external partners. Negotiate win-win outcomes, actively manage audit preparations, and represent the companies interests externally.
- Decision-Making & Problem-Solving: Exercise sound judgment and courage in decision-making, often with incomplete information. Proactively identify risks, implement cost-effective solutions, and push decision-making to the appropriate level.
- Leadership & Team Culture: Foster an inclusive team environment, mentor junior staff, champion data stewardship, and drive the adoption of new technologies to increase productivity.
- Communication: Clearly articulate complex ideas, resolve conflicts with transparency, and build trust across diverse teams.
Candidate Requirements
- 3-5 years experience with a PhD degree; 5-7 with Master’s degree or 6-8 years with Bachelor’s degree in the field of IVDs/Medical Devices/Pharma/Biopharmaceutical with significant experience in Regulatory Affairs or equivalent.
- Previous regulatory experience with FDA submissions for software or instrumentation in the medical device, biotech, or in-vitro diagnostics industry.
- Exceptional stakeholder management, communication, and conflict navigation.
- Has demonstrated the ability to manage high complexity work and/or global projects.
- Knowledge of the European, U.S., China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.
Pay ranges between 40-55/hr based on experience
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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