Senior Manager, Regulatory Affairs [Remote]

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Manager, Regulatory Affairs based in United States.

This role offers the opportunity to lead global regulatory strategies that support the development and commercialization of innovative medical technologies.
You will provide regulatory leadership across product lifecycles, ensuring compliance while enabling safe and efficient market access.
The position combines strategic thinking, technical expertise, and cross-functional collaboration within a highly regulated healthcare environment.
You will work closely with engineering, quality, clinical, operations, and business teams to integrate regulatory excellence into product development.
Your expertise will help navigate complex regulatory landscapes, manage risks, and support sustainable business growth.
This is a high-impact leadership opportunity for a regulatory professional passionate about improving healthcare outcomes through innovation.

Accountabilities:

The Senior Manager, Regulatory Affairs will provide strategic regulatory leadership for medical device portfolios, ensuring compliance with global regulations while supporting innovation, product development, and market access objectives. This role requires strong regulatory expertise, leadership capabilities, and the ability to influence stakeholders across global teams.

• Develop and execute comprehensive global regulatory strategies aligned with business goals, product roadmaps, and market access requirements.
• Lead regulatory pathways for U.S., EU, and international markets, including FDA Class I and II submissions, 510(k) processes, and EU MDR technical documentation.
• Integrate regulatory requirements into early product development phases, including design controls, risk management, verification and validation planning, and technical documentation.
• Identify regulatory risks, emerging requirements, and compliance challenges while developing effective mitigation strategies.
• Act as the regulatory authority within cross-functional product teams, partnering with engineering, quality, operations, marketing, and clinical teams.
• Evaluate regulatory impacts of product changes, manufacturing updates, supplier changes, labeling revisions, and lifecycle activities.
• Oversee preparation, review, and submission readiness of regulatory dossiers and technical documentation.
• Serve as a primary regulatory contact with health authorities, including FDA, EU Notified Bodies, and other international regulatory organizations.
• Support post-market regulatory activities, including reporting obligations, corrective actions, field actions, inspections, audits, and compliance initiatives.
• Mentor regulatory professionals and promote continuous improvement of regulatory processes, tools, and best practices.
• Represent Regulatory Affairs across the organization by providing strategic guidance and regulatory expertise.

Requirements:

The ideal candidate is an experienced medical device regulatory leader with a strong understanding of global compliance requirements and a proven ability to guide complex regulatory initiatives. You should have excellent communication skills, strategic judgment, and experience operating in global, matrixed environments.

• Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related discipline; advanced degree preferred.
• 8–10+ years of progressive regulatory affairs experience within the medical device industry.
• Demonstrated experience leading FDA Class I and II submissions, including 510(k) submissions.
• Experience with EU MDR (2017/745) technical documentation, conformity assessments, and global regulatory frameworks.
• Direct experience engaging with FDA and EU Notified Bodies; experience with additional international regulatory authorities is preferred.
• Strong knowledge of FDA regulations, including 21 CFR 820/QMSR, 21 CFR 807, 803, and 806.
• Deep understanding of ISO 13485, ISO 14971, quality systems, risk management, complaint handling, and regulatory reporting requirements.
• Experience supporting FDA inspections, audits, and regulatory compliance activities.
• Strong regulatory writing, documentation oversight, and submission planning skills.
• Ability to align regulatory strategies with engineering, quality, and business priorities.
• Excellent leadership, mentoring, negotiation, and stakeholder management abilities.
• Strong analytical, organizational, and problem-solving skills with the ability to manage multiple priorities.
• RAC certification or equivalent regulatory certification is a plus.
• Willingness to travel periodically (approximately 20%) for audits, regulatory meetings, and collaboration activities.

Benefits:

• Competitive salary range of approximately $161,920 - $202,400, depending on experience and location.
• Target annual bonus opportunity of 25%.
• Remote work flexibility.
• Comprehensive health, dental, and vision insurance coverage.
• 401(k) retirement plan with company matching contributions.
• Paid time off and holiday benefits.
• Wellness programs and health assistance resources.
• Life insurance coverage.
• Short-term and long-term disability benefits.
• Health and dependent care flexible spending accounts.
• Commuter benefits.
• Parental and caregiver leave programs.
• Tuition reimbursement opportunities.
• Opportunity to work on impactful healthcare technologies within a global and collaborative environment.

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.