Mobia

1 week ago

Vice President, Quality Assurance & Regulatory Affairs

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 minutes agoStatus: Live

Job Summary

Lead Mobia Medical’s global Quality Assurance and Regulatory Affairs strategy, overseeing the Quality Management System (QMS) and regulatory compliance across FDA and international requirements. Manage post-market surveillance, MDR/vigilance, CAPA, risk management, and design assurance—including design controls, traceability, and transfer to production. Own regulatory strategies (IDE, 510(k), PMA, De Novo, CE Mark), lead inspections and audits, and build/mentor a high-performing global quality organization.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Sr. Director level

Key Responsibilities

•Provide strategic leadership for global Quality Assurance and Regulatory Affairs, anticipating scope and scaling capability/capacity as the company grows.
•Develop, maintain, and continuously improve the company QMS to ensure compliance with FDA regulations, ISO 13485, cGMPs, EU MDR, and other applicable standards.
•Oversee post-market surveillance and quality/regulatory risk management, including MDR/vigilance, CAPA, field actions, and enterprise-wide risk processes.
•Lead regulatory strategy and submissions (IDE, 510(k), PMA, De Novo, CE Mark) while serving as the Person Responsible for Regulatory Compliance (PRRC-MDR).
•Lead FDA inspections, global regulatory audits, and interactions with health authorities; mentor and build a high-performing quality and regulatory organization.

Pay and Benefits

Perks:Health InsuranceDentalVisionFsa401kPaid LeavePaid Holidays

Key Requirements

•Bachelor's degree in a scientific, engineering, or other technical discipline.
•15+ years of progressive leadership experience in Quality Assurance and Regulatory Affairs within the medical device industry.
•Deep expertise supporting Class II and/or Class III medical devices, with experience in active implantable medical devices strongly preferred.
•Extensive knowledge of FDA regulations and quality/regulatory standards including ISO 13485 and ISO 14971, EU MDR, and FDA 21 CFR Parts 801, 803, 806, and 820.
•Demonstrated success leading FDA inspections, international regulatory submissions, and global quality management systems.

Experience:15+ yearsMedical devicesMedtechImplantable medical devices

Education:Bachelor's

Skills:LeadershipCommunicationCross-functional collaborationOrganizationalStrategic planning

Certifications:Regulatory Affairs Certification (RAC)American Society for Quality (ASQ) certification

Tech Stack:Quality Management System (QMS)FDA 21 CFR Part 820FDA regulationsISO 13485ISO 14971CGMPsEU MDRFDA 21 CFR Part 801FDA 21 CFR Part 803FDA 21 CFR Part 806Post-market surveillanceMedical Device Reporting (MDR)VigilanceCAPARisk managementDesign controlsDesign history fileDesign transferIDE510(k)

Company Brief

Mobia

MCIM 24x7 provides round-the-clock IT infrastructure monitoring, managed services, network and security support, and cloud infrastructure management for businesses seeking continuous operational uptime and technical support.

Industry: Professional Services

Website

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Mobia

1 week ago

Vice President, Quality Assurance & Regulatory Affairs

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 minutes agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: Quality & Regulatory (Non-Software)

Seniority: Sr. Director level

Key Responsibilities

•Provide strategic leadership for global Quality Assurance and Regulatory Affairs, anticipating scope and scaling capability/capacity as the company grows.
•Develop, maintain, and continuously improve the company QMS to ensure compliance with FDA regulations, ISO 13485, cGMPs, EU MDR, and other applicable standards.
•Oversee post-market surveillance and quality/regulatory risk management, including MDR/vigilance, CAPA, field actions, and enterprise-wide risk processes.
•Lead regulatory strategy and submissions (IDE, 510(k), PMA, De Novo, CE Mark) while serving as the Person Responsible for Regulatory Compliance (PRRC-MDR).
•Lead FDA inspections, global regulatory audits, and interactions with health authorities; mentor and build a high-performing quality and regulatory organization.

Pay and Benefits

Perks:Health InsuranceDentalVisionFsa401kPaid LeavePaid Holidays

Key Requirements

•Bachelor's degree in a scientific, engineering, or other technical discipline.
•15+ years of progressive leadership experience in Quality Assurance and Regulatory Affairs within the medical device industry.
•Deep expertise supporting Class II and/or Class III medical devices, with experience in active implantable medical devices strongly preferred.
•Extensive knowledge of FDA regulations and quality/regulatory standards including ISO 13485 and ISO 14971, EU MDR, and FDA 21 CFR Parts 801, 803, 806, and 820.
•Demonstrated success leading FDA inspections, international regulatory submissions, and global quality management systems.

Experience:15+ yearsMedical devicesMedtechImplantable medical devices

Education:Bachelor's

Skills:LeadershipCommunicationCross-functional collaborationOrganizationalStrategic planning

Certifications:Regulatory Affairs Certification (RAC)American Society for Quality (ASQ) certification

Company Brief

Mobia

Industry: Professional Services

Website