Skills Alliance
Consultant | Medical Devices | QARA United States & Europe
Role:
Head of Quality & Regulatory Affairs – Medical Devices (Class III Neuromodulation)
Location:
Massachusetts
Employment Type:
Full-time (Hybrid)
Our client, a rapidly growing neuromodulation company, is developing a portfolio of Class III implantable neurostimulation devices aimed at treating complex neurological conditions. These technologies have the potential to redefine patient care in the neurotech space. We are seeking an experienced Head of Quality & Regulatory Affairs to lead the QARA function through late-stage development, PMA approval, and international expansion.
Role Overview The Head of QARA will be responsible for shaping and executing the company’s U.S. and global quality and regulatory strategy. This executive will lead all regulatory interactions (including FDA PMAs and EU MDR pathways), manage the Quality Management System (QMS) to the highest international standards, and build a compliant infrastructure for Class III active implantables. The role involves close cross‑functional collaboration with R&D, Clinical, and Operations teams to ensure readiness for commercialisation and long‑term compliance.
Key Responsibilities
Lead the company’s regulatory strategy and execution for Class III neuromodulation devices, including PMA submissions, IDEs, and global market approvals (EU MDR, TGA, Health Canada).
Design, implement, and maintain a scalable QMS in compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and MDSAP requirements.
Oversee all quality functions, including design controls, risk management, supplier quality, and CAPA processes.
Guide and support clinical and regulatory documentation, including DHFs, DMRs, and labelling in line with neuromodulation‑specific standards (e.g., IEC 60601, IEC 62304, ISO 10993).
Act as the primary point of contact during FDA inspections and Notified Body audits.
Lead and mentor a high‑performing QARA team, fostering a proactive quality culture throughout the organisation.
Serve as a key advisor to the executive team on risk management, product launch readiness, and international compliance.
Qualifications
12+ years of progressive QARA leadership experience in the medical device industry, including direct oversight of
Class III implantable or neuromodulation systems .
Demonstrated success in navigating FDA PMA and global regulatory approvals.
Expertise in ISO 13485, ISO 14971, EU MDR, and standards for active implantable and software‑driven devices (IEC 60601, 62304).
Strong background in design controls, clinical regulatory strategy, and post‑market surveillance.
Proven ability to lead cross‑functional teams in a fast‑paced, innovative medtech environment.
Executive presence, with the communication and leadership skills to influence across technical and commercial functions.
Bachelor’s degree in biomedical engineering, life sciences, or related field (Master’s or RAC preferred).
Salary & Benefits Cambridge, MA – $240,000.00–$330,000.00
Referrals increase your chances of interviewing at Skills Alliance by 2x.
#J-18808-Ljbffr
Head of Quality & Regulatory Affairs – Medical Devices (Class III Neuromodulation)
Location:
Massachusetts
Employment Type:
Full-time (Hybrid)
Our client, a rapidly growing neuromodulation company, is developing a portfolio of Class III implantable neurostimulation devices aimed at treating complex neurological conditions. These technologies have the potential to redefine patient care in the neurotech space. We are seeking an experienced Head of Quality & Regulatory Affairs to lead the QARA function through late-stage development, PMA approval, and international expansion.
Role Overview The Head of QARA will be responsible for shaping and executing the company’s U.S. and global quality and regulatory strategy. This executive will lead all regulatory interactions (including FDA PMAs and EU MDR pathways), manage the Quality Management System (QMS) to the highest international standards, and build a compliant infrastructure for Class III active implantables. The role involves close cross‑functional collaboration with R&D, Clinical, and Operations teams to ensure readiness for commercialisation and long‑term compliance.
Key Responsibilities
Lead the company’s regulatory strategy and execution for Class III neuromodulation devices, including PMA submissions, IDEs, and global market approvals (EU MDR, TGA, Health Canada).
Design, implement, and maintain a scalable QMS in compliance with ISO 13485, 21 CFR Part 820, ISO 14971, and MDSAP requirements.
Oversee all quality functions, including design controls, risk management, supplier quality, and CAPA processes.
Guide and support clinical and regulatory documentation, including DHFs, DMRs, and labelling in line with neuromodulation‑specific standards (e.g., IEC 60601, IEC 62304, ISO 10993).
Act as the primary point of contact during FDA inspections and Notified Body audits.
Lead and mentor a high‑performing QARA team, fostering a proactive quality culture throughout the organisation.
Serve as a key advisor to the executive team on risk management, product launch readiness, and international compliance.
Qualifications
12+ years of progressive QARA leadership experience in the medical device industry, including direct oversight of
Class III implantable or neuromodulation systems .
Demonstrated success in navigating FDA PMA and global regulatory approvals.
Expertise in ISO 13485, ISO 14971, EU MDR, and standards for active implantable and software‑driven devices (IEC 60601, 62304).
Strong background in design controls, clinical regulatory strategy, and post‑market surveillance.
Proven ability to lead cross‑functional teams in a fast‑paced, innovative medtech environment.
Executive presence, with the communication and leadership skills to influence across technical and commercial functions.
Bachelor’s degree in biomedical engineering, life sciences, or related field (Master’s or RAC preferred).
Salary & Benefits Cambridge, MA – $240,000.00–$330,000.00
Referrals increase your chances of interviewing at Skills Alliance by 2x.
#J-18808-Ljbffr