Regulatory Affairs Sustaining Software Consultant

Summary

Join RQM+, a leading MedTech solutions partner, as a Regulatory Affairs Consultant. You will leverage your expertise to develop and maintain regulatory strategies, ensuring compliance with FDA and EU MDR regulations. Responsibilities include driving regulatory compliance, leading cross-functional teams, managing global coordination of device registrations, and authoring various regulatory submissions. The ideal candidate possesses a Bachelor's degree in a related field with 5-10 years of experience in regulatory affairs within the medical device industry. A strong understanding of medical device regulations, including experience with 510(k)s, PMAs, and EU MDR submissions, is essential. RQM+ offers an industry-leading compensation package and a focus on work-life balance.

Requirements

• Bachelor’s Degree in related field with 5-10 years of experience
• 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
• Self-motivated individual with a lead by example approach that endorses the company’s values and culture
• 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

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

Preferred Qualifications

• Engineering degree preferred
• Regulatory Affairs Certification (RAC) preferred
• 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

Benefits

• Industry leading compensation package
• Work life balance
• Ongoing learning and development