Quality & Regulatory Director — Hybrid (4 days in office)

ALKU; Boston (MA); Hybrid; USD 180.000 - 260.000; Vollzeit

Zusammenfassung

ALKU in Boston is seeking a Director of Quality and Regulatory to lead the quality team and oversight of regulatory operations for electromechanical capital systems and consumables. The role guides design controls, regulatory strategy, and post-market activities, ensuring alignment with FDA and global requirements.

The position requires expertise across QMS, CAPA, MDR, and risk management, with experience in inspections and submissions.

Qualifikationen

• Demonstrated experience leading Quality and Regulatory Compliance programs within the medical device industry.
• Strong working knowledge of FDA medical device regulations including 21 CFR Part 820, Design Controls, CAPA, MDR, and Post-Market Surveillance.
• Experience supporting FDA inspections, ISO 13485 certification audits, and regulatory submissions.
• Proven ability to manage regulatory compliance activities across product development, manufacturing, commercialization, and post-market surveillance.
• Experience with risk management methodologies, including ISO 14971, preferred.
• Regulatory affairs certification (RAC) or CQE/CQA preferred.

Aufgaben

• Provide strategic leadership and oversight of the company's Quality Management System (QMS) and Regulatory Compliance programs.
• Serve as the primary quality representative during regulatory inspections, audits, and interactions with regulatory agencies, including the FDA.
• Develop and execute regulatory strategies supporting product development, approvals, labeling changes, and post-market requirements.
• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, MDR, CAPA, risk management, and international regulations.
• Oversee internal and external audit programs, supplier quality management, and inspection readiness initiatives.
• Provide guidance on regulatory risks, remediation activities, and quality system improvements.
• Lead quality and regulatory review for design controls, verification/validation, software validation, change control, and product lifecycle management.
• Establish quality metrics and report status to executive leadership.
• Maintain relationships with regulatory agencies, auditors, consultants, and industry bodies.

Kenntnisse

Strategic leadership

Regulatory compliance

FDA regulations

Quality management

Cross-functional leadership

Ausbildung

Bachelor's degree in Engineering, Life Sciences, or related field

RAC or CQE/CQA preferred

Tools

QMS systems

Regulatory submissions

FDA inspections

Jobbeschreibung

ALKU in Boston is seeking a Director of Quality and Regulatory to lead the quality team and oversight of regulatory operations for electromechanical capital systems and consumables. The role guides design controls, regulatory strategy, and post-market activities, ensuring alignment with FDA and global requirements.

The position requires expertise across QMS, CAPA, MDR, and risk management, with experience in inspections and submissions.