Regulatory Affairs Sustaining Software with Robotics Support Consultant

Regulatory and Quality Solutions LLC (R&Q) United States - Remote Temporary

 RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
As Regulatory Affairs Consultant you will be responsible for providing regulatory and quality expertise to both clients and the RQM+ Team by researching and developing strategies and submissions to ensure compliance with the appropriate regulations while creating overall customer satisfaction.  

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, and/or Global Markets).
  • 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, and neuromodulation therapies.

Requirements:

  • 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.