Manager Quality Assurance & Reg Affairs | AirStrip

Jobgether; United States; On-site; USD 101,000 - 126,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Paid time off

401(k) with company match

Paid holidays

Parental leave

Job summary

Jobgether on behalf of a partner company seeks a Manager Quality Assurance & Regulatory Affairs in the United States to lead QA and regulatory activities for SaMD products. You will drive QMS improvements, ensure FDA and international compliance, and mentor teams across cross-functional product development, clinical, and operations.

You will oversee audits, CAPA, risk management, and regulatory submissions to support global market authorizations, while continually advancing quality processes in

Qualifications

• Bachelor’s degree in Healthcare, IT, Quality Management, or related field.
• At least 5 years in QA and Regulatory Affairs for medical devices.
• Strong knowledge of FDA guidance, 21 CFR Part 820, and international regulations.
• Experience with MDSAP, MDR, UKCA, ISO 13485, and QMSR.
• Proven risk assessment and CAPA capabilities.
• Experience improving and maintaining QMS; audit readiness.

Responsibilities

• Lead QA and Regulatory activities across the product lifecycle.
• Maintain QMS documentation to comply with FDA and international standards.
• Support audits by notified bodies and regulators.
• Coordinate DHF, Technical Files, Risk Management, and clinical eval documentation.
• Manage CAPAs and corrective actions to prevent recurrence.
• Oversee internal and supplier audits and analyze CAPA data.
• Support regulatory submissions and market authorizations globally.
• Mentor and train team members on quality and regulatory best practices.

Skills

QMS

Regulatory Affairs

FDA Guidance

Risk Management

CAPA

Audits

Cross-functional

Regulatory Submissions

Education

Bachelor’s degree in related field

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 Manager Quality Assurance & Regulatory Affairs | AirStrip based in the United States.

In this role, you will lead Quality Assurance and Regulatory Affairs activities within a medical technology environment, ensuring the highest standards of product quality, safety, and regulatory compliance. You will oversee the continuous improvement of the Quality Management System (QMS) while supporting the development and enhancement of innovative Software as a Medical Device (SaMD) solutions. Working cross-functionally with product development, clinical, and operational teams, you will contribute to regulatory strategy, risk management, and product lifecycle oversight. You will also play a key role in audit readiness, corrective action initiatives, and international market authorizations. This position offers the opportunity to influence quality processes, strengthen regulatory frameworks, and mentor team members in a dynamic, innovation-driven healthcare technology environment.

Accountabilities

• Develop, implement, and maintain Quality System Documentation (QSDs) to ensure compliance with FDA regulations, 21 CFR Part 820, MDSAP requirements, and other applicable standards governing Software as a Medical Device (SaMD).
• Support external audits and inspections conducted by notified bodies and regulatory authorities, providing expertise and ensuring audit readiness.
• Collaborate with New Product Development (NPD) and Existing Product Enhancement (EPE) teams throughout the product lifecycle, contributing to Design History Files (DHF), Technical Files, Risk Management Files, Clinical Evaluation Reports, and Post-Market Surveillance documentation.
• Participate in nonconforming product and customer complaint processes, ensuring issues are properly identified, documented, evaluated, investigated, and resolved in a timely manner.
• Lead and support Corrective and Preventive Action (CAPA) initiatives to address systemic quality issues, prevent recurrence, and drive continuous improvement.
• Coordinate internal and supplier audits, ensuring they are conducted according to established audit programs, applicable regulations, and international quality standards.
• Monitor and analyze CAPA, complaint, clinical evaluation, and post-market surveillance data, preparing reports and insights for management review meetings.
• Maintain and support international regulatory certifications and market authorizations, including ISO 13485:2016, MDSAP, MDD/MDR, UKCA, and CMDCAS registrations.
• Build and maintain a regulatory and compliance knowledge base to facilitate access to current requirements, monitor regulatory changes, and generate compliance performance insights.

Requirements

• Bachelor's degree in Healthcare, Information Technology, Quality Management, or a related discipline. Equivalent professional experience may be considered in place of a degree.
• At least 5 years of experience managing Quality Assurance and Regulatory Affairs activities within the medical device industry.
• Minimum 5 years of experience interpreting and applying FDA guidance, regulations, and requirements from international regulatory authorities.
• Proven knowledge of medical device quality and regulatory frameworks, including MDSAP, MDR, UKCA, ISO 13485, and QMSR.
• Strong understanding of risk assessment, risk management methodologies, and regulatory compliance processes.
• Experience managing and continuously improving Quality Management Systems, including CAPA, complaint handling, audits, and post-market surveillance.
• Excellent organizational, planning, coordination, and follow-up skills, with strong attention to detail.
• Outstanding written and verbal communication skills, with the ability to collaborate effectively across multidisciplinary teams.
• Strong analytical thinking and problem-solving abilities, combined with a proactive, results-oriented approach.
• Creative and innovative mindset, with the ability to identify opportunities for process improvement and operational excellence.
• Demonstrated ability to coach, mentor, and support team members while fostering a culture of accountability and continuous improvement.

Benefits

• Annual base salary: $100,700–$126,000, depending on qualifications, professional experience, and geographic location.
• Comprehensive medical, dental, and vision insurance coverage.
• Paid Time Off for hourly employees and Flex Time Off for salaried employees.
• 401(k) retirement savings plan with a 3% company match.
• Paid holidays.
• Paid parental leave, including a flexible return-to-work program.
• Life and disability insurance.
• Employee Assistance Program (EAP).
• Financial planning assistance.
• Physical and mental wellness programs and discounts.
• Access to an online learning platform and professional development opportunities.
• Discounts on selected mobile phone plans.
• Additional employee wellness, growth, development benefits.
• Travel may be required as part of the position.

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!

Why Apply Through Jobgether?

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.

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.