Principal, RA Specialist in United States at Jobgether
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Job Description
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Principal, RA Specialist based in United States.
This senior regulatory affairs role plays a critical part in enabling the global commercialization of innovative in vitro diagnostic products and software solutions.
You will be responsible for shaping and executing regulatory strategies that ensure timely market access across multiple global regions.
The position serves as a key subject matter expert within the regulatory function, guiding complex submissions and supporting product development from a compliance perspective.
You will collaborate closely with cross-functional teams to ensure regulatory requirements are embedded throughout design, development, and commercialization stages.
The role requires strong expertise in global regulatory frameworks, combined with the ability to interpret evolving requirements and translate them into actionable guidance.
You will also act as a mentor to junior team members, helping elevate overall team capability and regulatory excellence.
This is a highly influential role at the intersection of innovation, compliance, and global healthcare impact.
- Lead the preparation, authoring, and submission of global regulatory filings, including technical files, registrations, listings, and submissions required for product approvals.
- Collaborate with international regulatory counterparts to ensure timely and compliant submission of documentation across multiple global markets.
- Provide regulatory guidance and approval for design control deliverables, product development documentation, protocols, reports, and marketing materials.
- Assess regulatory risks and interpret evolving global regulations, ensuring alignment with corporate standards, SOPs, and applicable agency requirements.
- Support product development teams by ensuring regulatory requirements are integrated into design control, risk management, and lifecycle processes.
- Act as a subject matter expert on global IVD regulatory frameworks, providing strategic input on compliance, submissions, and regulatory pathways.
- Mentor and support junior and intermediate regulatory associates, fostering knowledge sharing and team development.
- Bachelor’s degree in a technical or scientific field such as biology, biochemistry, chemistry, or related discipline.
- 7+ years of experience in a regulated industry, including at least 4+ years in global regulatory affairs within in vitro diagnostics (IVD).
- Strong knowledge of FDA and EU regulatory frameworks, including experience with PMA, 510(k), De Novo submissions, and technical documentation.
- Deep understanding of design control, risk management, and product development processes within regulated environments.
- Familiarity with ISO 13485, IVDR, and 21 CFR Part 820 requirements.
- Strong analytical, research, and problem-solving skills with the ability to manage multiple complex regulatory projects independently.
- Excellent communication and collaboration skills, with the ability to build consensus across global, cross-functional teams.
- Demonstrated ability to provide regulatory leadership and mentorship in a matrixed environment.
- Annual salary range of $110,000 – $135,000 with eligibility for bonus and incentive compensation.
- Comprehensive benefits package including medical, dental, and vision insurance.
- 401(k) retirement savings plan for eligible employees.
- Paid time off and flexible remote work arrangement for eligible roles.
- Opportunity to work on globally impactful in vitro diagnostic innovations.
- Mentorship and leadership opportunities within a high-performing regulatory team.