Offer summary

Qualifications:

Bachelor's Degree in a related field, engineering preferred., 5-10 years of experience in Regulatory Affairs., Experience with medical devices, including regulatory submissions like 510(k)s, PMA, and EU MDR., Knowledge of AI/ML, cybersecurity, and related standards in medical technology..

Key responsibilities:

Develop and maintain Regulatory Affairs Strategies for product compliance.

Drive regulatory compliance with FDA, EU MDR, and other standards.

Lead cross-functional teams on regulatory compliance and mentor professionals.

Manage global registration and changes for surgical devices and implants.

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 endtoend expertise to propel products from concept through market entry and ongoing postmarket support.

Our tailored solutions bring unmatched regulatory and quality expertise, FDArecognized 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 lifechanging 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 crossfunctional teams on regulatory compliance while mentoring regulatory professionals.
Manage global coordination and registration of advanced surgical devices and implants, as well as changes to marketreleased class II & class III devices for surgical devices, fixation implants therapies.

Requirements:
Bachelor’s Degree in related field with 510 years of experience. Engineering degree preferred.
Experience in Regulatory Affairs
Experience with AIML (Artificial IntelligenceMachine Learning), robotics, cybersecurity, and threat modeling.
Experience with adpromo review and preclinical research.
Authored 510(k)s, PMA, HDE, IDE, QSubmissions, EU MDR Tech Files Dossiers, and regulatory submissions and compliance to ISO 14971, ISO 10993, IEC 60601, IEC 80601277 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.
Selfmotivated 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 problemsolving 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.comcareers Every candidate going through the interview process will participate in a voice andor video interview. Exercise caution with unsolicited job offers or requests for sensitive information.

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.comcareers
Every candidate going through the interview process will participate in a voice andor video interview.
Exercise caution with unsolicited job offers or requests for sensitive information.