Regulatory Affairs Manager

Skillcloud HCM Solutions

. Develop and implement global regulatory strategies that support product development, commercialization, and lifecycle management of medical devices.

Posted 10/15/2026full-timeUnited StatesSeniorLead💰 $120,000 - $140,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in developing and implementing regulatory strategies for medical devices, ensuring compliance with FDA, MDR, and international regulations. Proven leadership in guiding regulatory affairs teams and managing regulatory submissions and interactions with authorities.

Highest-signal resume keywords

Regulatory Affairs LeadershipFDA SubmissionsISO 13485 ComplianceMedical Device RegulationsGlobal Market Access

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Filing PreparationProduct Registration MaintenanceRegulatory Review of Product ClaimsQuality Management System Integration

Soft Skills

MentoringCollaborationAdvisory Skills

Certifications & Qualifications

Regulatory Affairs Certification (RAC)ASQ Certified Quality Auditor (CQA)ASQ Certified Quality Engineer (CQE)ISO 13485 Lead Auditor Certification

Industry Keywords

Medical DevicesFDAMDRUK RegulationsCanada RegulationsMDSAPClass II Medical DevicesClass III Medical Devices

About the role

Key responsibilities & impact

Develop and implement global regulatory strategies that support product development, commercialization, and lifecycle management of medical devices.
Provide regulatory leadership and guidance throughout all phases of product design, development, verification, validation, release, and post-market support.
Advise executive leadership on regulatory risks, opportunities, emerging regulations, and business impacts.
Lead, mentor, and develop Regulatory Affairs personnel.
Oversee preparation, review, submission, and maintenance of regulatory filings.
Ensure timely maintenance of product registrations in all approved markets.
Manage interactions with regulatory authorities, notified bodies, distributors, and international representatives.
Ensure regulatory compliance is integrated into the Quality Management System (QMS).
Participate in internal audits, external audits, supplier audits, and regulatory inspections.
Collaborate with Engineering and Product Development teams to ensure regulatory requirements are appropriately incorporated into product designs.
Provide regulatory review and approval of product claims, labeling, instructions for use, advertising, promotional materials, and marketing communications.
Support design reviews and development projects as a core regulatory stakeholder.
Maintain awareness of emerging regulations, guidance documents, standards, and industry best practices.

Requirements

What you’ll need

Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, Quality, or related technical discipline required. Master's degree preferred.
Minimum of 7-10 years of medical device regulatory affairs experience.
Minimum of 3 years of leadership, supervisory, or project leadership experience.
Demonstrated experience with FDA submissions, international registrations, and global market access activities.
Experience with FDA, MDR, UK, Canada, and MDSAP requirements.
Experience with Class II and/or Class III medical devices preferred.
Experience supporting ISO 13485-certified and FDA-regulated environments required.
RAC (Regulatory Affairs Certification), ASQ Certified Quality Auditor (CQA), ASQ Certified Quality Engineer (CQE), ISO 13485 Lead Auditor Certification preferred.

Benefits

Comp & perks

Health and Dental Insurance options
401K with company match
Employee Stock Ownership Plan
Generous PTO, holiday pay, paid sick time
Up to $1000/ year for approved professional development
Options for Life Insurance, HSA and DCA Accounts
Flexible work schedule with the opportunity for hybrid work 1-2 days/week