InnoTech Staffing
VP / Head of Quality and Regulatory - medical device
InnoTech Staffing, Cambridge, Massachusetts, us, 02140
Job Description
Job Description
InnoTECH Staffing is looking to hire a VP or Head of QA / RA - Quality Assurance and Regulatory Assurance Engineer for an exciting medical device / drug delivery start-up in the Cambridge, MA area. There is some flexibility but would like this person onsite as much as possible.
This role will be heavy on the Quality side of things. There is already a QMS in place. Will work with external resources and drive those efforts. Will need to sign every document.
Looking for someone who is hands‑on and can manage.
Position Summary The Head of Quality and Regulatory will provide strategic vision and hands‑on leadership to establish and maintain robust Quality Management Systems (QMS) across the organization. This role involves close collaboration with R&D, Clinical, Operations, and senior management to embed a culture of quality, ensure regulatory compliance for all products (e.g., medical devices, SaMD, combination products), and manage all interactions with regulatory agencies (e.g., FDA, EMA).
Key Responsibilities
Quality Management System (QMS) Leadership : Develop, implement, and enhance a scalable QMS that is compliant with all applicable domestic and international regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR / IVDR, MDSAP).
Regulatory Strategy and Submissions : Lead the development and execution of regulatory strategies, manage submissions (e.g., 510(k), EU MDR), and act as the primary liaison with global health authorities to obtain and maintain product approvals.
Audits and Inspections : Ensure the company is "inspection ready" at all times. Prepare for, host, and manage all regulatory inspections and external audits, ensuring positive outcomes.
Risk Management and CAPA : Oversee risk management activities, lead investigations into significant quality issues (non-conformances, deviations), and ensure effective root cause analysis and implementation of Corrective and Preventive Actions (CAPA).
Product Lifecycle Quality : Ensure quality and compliance throughout the entire product lifecycle, from design controls in new product development to post-market surveillance activities including complaint handling and vigilance reporting.
Cross-Functional Collaboration : Partner with R&D, engineering, and clinical teams to integrate quality system methods and design controls into product development, using methodologies such as Agile while meeting regulatory requirements.
Leadership and Talent Development : Build, mentor, and develop a high-performing quality and regulatory team, fostering a culture of accountability and continuous improvement across the organization.
Performance Monitoring : Establish and monitor Key Performance Indicators (KPIs) and present quality metrics, trends, and recommendations for improvement to senior management and the Board of Directors.
Supplier Quality : Direct supplier quality controls, including qualification, auditing, and developing quality agreements with key vendors and contract manufacturers.
Qualifications and Experience
Education : Bachelor's degree in Engineering, Life Sciences, or a related field (Master's preferred).
Experience : Minimum of 10-15 years of experience in a Quality Assurance or Regulatory Affairs role within the medical device / pharmaceutical / biotech industry, with at least 5 years in a leadership / management position.
Regulatory Expertise : Deep and current understanding of global regulations and guidelines, including FDA (21 CFR Part 820, GCP, cGMP), ISO 13485, ISO 14971, MDR / IVDR, and MDSAP.
Skills : Strong leadership, analytical, problem‑solving, and decision‑making skills. Excellent oral and written communication skills with the ability to influence stakeholders at all levels.
Certifications : ASQ Certifications (CQA, CQE) or Lean Six Sigma certification a plus.
Environment : Confirmed ability to thrive in a dynamic, fast‑paced entrepreneurial environment, taking an expansive view of responsibilities.
Compensation includes base salary, bonus and equity.
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Job Description
InnoTECH Staffing is looking to hire a VP or Head of QA / RA - Quality Assurance and Regulatory Assurance Engineer for an exciting medical device / drug delivery start-up in the Cambridge, MA area. There is some flexibility but would like this person onsite as much as possible.
This role will be heavy on the Quality side of things. There is already a QMS in place. Will work with external resources and drive those efforts. Will need to sign every document.
Looking for someone who is hands‑on and can manage.
Position Summary The Head of Quality and Regulatory will provide strategic vision and hands‑on leadership to establish and maintain robust Quality Management Systems (QMS) across the organization. This role involves close collaboration with R&D, Clinical, Operations, and senior management to embed a culture of quality, ensure regulatory compliance for all products (e.g., medical devices, SaMD, combination products), and manage all interactions with regulatory agencies (e.g., FDA, EMA).
Key Responsibilities
Quality Management System (QMS) Leadership : Develop, implement, and enhance a scalable QMS that is compliant with all applicable domestic and international regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR / IVDR, MDSAP).
Regulatory Strategy and Submissions : Lead the development and execution of regulatory strategies, manage submissions (e.g., 510(k), EU MDR), and act as the primary liaison with global health authorities to obtain and maintain product approvals.
Audits and Inspections : Ensure the company is "inspection ready" at all times. Prepare for, host, and manage all regulatory inspections and external audits, ensuring positive outcomes.
Risk Management and CAPA : Oversee risk management activities, lead investigations into significant quality issues (non-conformances, deviations), and ensure effective root cause analysis and implementation of Corrective and Preventive Actions (CAPA).
Product Lifecycle Quality : Ensure quality and compliance throughout the entire product lifecycle, from design controls in new product development to post-market surveillance activities including complaint handling and vigilance reporting.
Cross-Functional Collaboration : Partner with R&D, engineering, and clinical teams to integrate quality system methods and design controls into product development, using methodologies such as Agile while meeting regulatory requirements.
Leadership and Talent Development : Build, mentor, and develop a high-performing quality and regulatory team, fostering a culture of accountability and continuous improvement across the organization.
Performance Monitoring : Establish and monitor Key Performance Indicators (KPIs) and present quality metrics, trends, and recommendations for improvement to senior management and the Board of Directors.
Supplier Quality : Direct supplier quality controls, including qualification, auditing, and developing quality agreements with key vendors and contract manufacturers.
Qualifications and Experience
Education : Bachelor's degree in Engineering, Life Sciences, or a related field (Master's preferred).
Experience : Minimum of 10-15 years of experience in a Quality Assurance or Regulatory Affairs role within the medical device / pharmaceutical / biotech industry, with at least 5 years in a leadership / management position.
Regulatory Expertise : Deep and current understanding of global regulations and guidelines, including FDA (21 CFR Part 820, GCP, cGMP), ISO 13485, ISO 14971, MDR / IVDR, and MDSAP.
Skills : Strong leadership, analytical, problem‑solving, and decision‑making skills. Excellent oral and written communication skills with the ability to influence stakeholders at all levels.
Certifications : ASQ Certifications (CQA, CQE) or Lean Six Sigma certification a plus.
Environment : Confirmed ability to thrive in a dynamic, fast‑paced entrepreneurial environment, taking an expansive view of responsibilities.
Compensation includes base salary, bonus and equity.
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