Summary: The Regulatory Affairs Consultant at RQM+ will provide regulatory and quality expertise to clients and the RQM+ team, focusing on compliance with regulations and enhancing customer satisfaction. The role involves developing regulatory strategies, driving compliance with FDA and EU MDR, and managing global coordination for advanced surgical devices. The consultant will also lead cross-functional teams and mentor regulatory professionals. This position emphasizes a strong understanding of regulatory affairs in the MedTech industry.

Key Responsibilities:

• Develop and maintain Regulatory Affairs Strategies to release and maintain product in accordance with the Standards and Regulatory requirements.
• Drive regulatory compliance (FDA, EU MDR).
• SaMD submissions, Regulatory Assessments.
• Lead cross-functional teams on regulatory compliance while mentoring regulatory professionals.
• Manage global coordination and registration of advanced surgical devices and implants, as well as changes to market-released class II class III devices for surgical devices, fixation implants therapies.

Key Skills:

• Bachelor’s Degree in related field with 5-10 years of experience. Engineering degree preferred.
• Experience in Regulatory Affairs.
• Experience with AI/ML (Artificial Intelligence/Machine Learning), robotics, cybersecurity, and threat modeling.
• Experience with ad/promo review and preclinical research.
• Authored 510(k)s, PMA, HDE, IDE, Q-Submissions, EU MDR Tech Files / Dossiers, and regulatory submissions and compliance to ISO 14971, ISO 10993, IEC 60601, IEC 80601-2-77 and associated standards.
• Experience working with medical devices in a regulatory role in industry.
• Experience with sustaining change controls, manufacturing site changes, supplier changes, and manufacturing process changes.
• Regulatory Affairs Certification (RAC) preferred.
• Self-motivated individual with a lead by example approach that endorses the company’s values and culture.
• Working understanding of the RQM+ business, organization roles and responsibilities, the internal quality system, and operating systems and how to effectively maneuver within each preferred.
• Regulatory knowledge and technical background.
• Strong analytical, diagnostic, consulting and problem-solving skills and ability to tailor solutions to meet the needs of customers.
• Strong desire for continuous learning.
• Strong oral and written communication skills, including presentation skills and executive presence.
• Excellent interpersonal, communication and influencing skills and experience working with clients, employees, and the medical device industry.
• High performance orientation, a detail orientation, and strong organization skills.
• Advanced computer skills including data analysis and report writing required.
• Consulting services are focused on creating a culture of respect and continuous improvement with the aim of generating maximum value for customers and stakeholders by identifying value and eliminating waste in processes.

Salary (Rate): undetermined

City: undetermined

Country: undetermined

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other