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Regulatory Affairs Sustaining Software Consultant

Remote: 
Full Remote
Contract: 
Full time
Work from: 
United States

Offer summary

Qualifications:

Bachelor’s Degree in a related field with 5-10 years of experience, preferably in engineering., Experience in Regulatory Affairs and with medical devices in a regulatory role., Familiarity with AI/ML, robotics, cybersecurity, and regulatory submissions such as 510(k)s and EU MDR Tech Files., Strong analytical, communication, and problem-solving skills, with a desire for continuous learning..

Key responsabilities:

  • Develop and maintain Regulatory Affairs Strategies for product compliance with standards and regulations.
  • Drive regulatory compliance with FDA and EU MDR requirements.
  • Lead cross-functional teams on regulatory compliance and mentor regulatory professionals.
  • Manage global coordination and registration of advanced surgical devices and changes to market-released devices.

RQM+ logo
RQM+ SME https://www.rqmplus.com/
501 - 1000 Employees
See all jobs

Job description

RQM+ is the leading MedTech solutions partner, accelerating the product lifecycle from innovation to patient impact. While manufacturers create medical technology, we apply our end-to-end expertise to propel products from concept through market entry and ongoing post-market support.

Our tailored solutions bring unmatched regulatory and quality expertise, FDA-recognized laboratory and materials science, comprehensive clinical trial design and execution, and impactful reimbursement strategies — accelerating market entry and commercial growth. We partner closely with manufacturers across device types and therapeutic areas to deliver life-changing technologies to patients: faster, safer, better.

We don’t make MedTech. We make MedTech happen.

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).
  • 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.

    • 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.
    • Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. 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. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! 

    We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.


    Job Opportunity Verification
    At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:
    All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
    Every candidate going through the interview process will participate in a voice and/or video interview.
    Exercise caution with unsolicited job offers or requests for sensitive information.

    Required profile

    Experience

    Spoken language(s):
    English
    Check out the description to know which languages are mandatory.

    Hard Skills

    Regulatory ComplianceAI/ML InferenceRegulatory ComplianceMedical DevicesIEC 61508 StandardIEC 61508 StandardRegulatory ComplianceAnalyticsChange ControlISO 10993 StandardISO 13485 StandardRegulatory ComplianceCyber SecurityPreclinical ImagingThreat Modeling

    Other Skills

    • Report Writing
    • Communication
    • Analytical Skills
    • Organizational Skills
    • Social Skills
    • Problem Solving
    Are you interested?

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