Director Regulatory Affairs & Quality Management

Summary

Join RQM+, a leading MedTech solutions partner, as the Director, Regulatory Affairs and Quality Management. Lead a team of five, providing strategic direction and mentorship to ensure compliance with global regulatory requirements, particularly FDA and MDR for SaMD. Responsibilities include leading regulatory document preparation and submission, coordinating with regulatory authorities, developing and implementing regulatory strategies, and collaborating with cross-functional teams. You will also implement risk management practices, ensure alignment with QMS and regulatory standards, and oversee regular audits. The ideal candidate possesses 10+ years of regulatory affairs experience in the medical device industry, focusing on FDA and SaMD, along with a relevant bachelor's degree. RQM+ offers an industry-leading compensation package and a focus on work-life balance.

Requirements

• Bachelor’s degree in a relevant field (e.g., life sciences, engineering, regulatory affairs, quality management)
• 10+ years of regulatory affairs experience in the medical device industry, with a strong focus on FDA and SaMD
• Knowledge of 21 CFR, ISO13485 and ISO 27001
• Training in quality management and quality improvement processes
• Strong leadership and team management skills, with the ability to inspire and guide a diverse team
• Excellent communication and negotiation skills, with the ability to interact effectively with regulatory authorities and cross-functional teams
• Flexible, positive and well-organized team player, comfortable working in a fast-paced software and technology environment

Responsibilities

• Lead a high-performing regulatory and quality affairs team (team of five), fostering a culture of compliance and continuous improvement
• Provide strategic direction and mentorship to the regulatory and quality affairs team, ensuring alignment with organizational objectives
• Establish goals for the team and individual team members using knowledge of the industry in alignment with organizational objectives
• Lead Management Review with Executive Team and Board
• Lead the preparation, submission, and negotiation of regulatory documents, ensuring timely and successful approvals
• Coordinate with regulatory authorities, including the FDA, European and Australian regulatory bodies to facilitate the approval process
• Develop and implement regulatory strategies to ensure compliance with FDA, MDR, and other global regulatory requirements for medical devices
• Monitor and interpret regulatory developments and trends, advising General Counsel and Leadership Team on potential impacts
• Collaborate with cross-functional teams, including R&D, Product, and Marketing to integrate regulatory requirements into product development processes
• Implement robust risk management practices to identify and mitigate regulatory risks
• Ensure alignment with quality management systems (QMS) and regulatory standards, including but not limited to, 21 CFR 820, ISO 13285, and ISO 27001
• Oversee regular audits of the departments to ensure compliance with procedures
• Provide input into the department Budgeting process

Preferred Qualifications

Experience in the IT field, software development, and/or cloud hosting preferred

Benefits

From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals