Regulatory Affairs Consultant
United States - Remote
CRO – Regulatory, Reimbursement and Market Access /
Full-time /
Remote
RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better.
We don’t make MedTech. We make MedTech happen.
Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency
A Consultant with RQM+ is responsible for the delivery of service offerings. This role is responsible for the execution of the defined consulting scope of work. The Consultant contributes with the delivery of regulatory and quality solutions that are best practice, innovative, and enable client success through delivery of superior service under the direction of project leadership. The Consultant is focused on contributing to the delivery of regulatory services and to timely execute specific deliverables against timelines and budgets for projects.
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 Strategies to release and maintain product in accordance with the Standards and Regulatory requirements.
- Interface with regulatory agencies such as FDA and Notified Bodies (NB).
- Provide RA leadership/support to New Product Development (NPD) teams.
- Provide strategic direction on labeling, regulations, and standards.
- Support the regulatory aspects of medical devices and/or diagnostic devices across a range of classifications.
- Collaborate cross-functionally with R&D, manufacturing, medical, clinical, non-clinical and marketing to incorporate their reports into submissions.
- Create, edit, review, and maintain regulatory submissions to support country specific marketing approval. Ex: Technical Documentation, Design Dossiers, 510(k), IDE, PMA, de novo, etc.
- Submit and/or review PMAs/supplements/30-day notices.
- Obtain approvals for new medical devices, and/or SW and/or diagnostics and determine regulatory impact of design/process changes.
- Maintain product registration and review changes and registration updates as required to either regulators or NBs.
- Develop, maintain, review, product labels, Instructions for Use (IFU) and any associated marketing material for compliance with applicable regulations and technical standards.
- Participate in strategy development for reimbursement.
- Perform gap assessments and propose remediation for regulatory submissions including technical files to EU MDR and/or IVDR.
- Support International Registration Requests and coordinate device change communication to regulatory agencies across the globe as necessary
- Participate in project development teams and reviews plans, reports, risk management and design reviews associated with product and process projects intended for inclusion in regulatory submissions.
- Provide acquisition due diligence and integration.
- Review and provide input on clinical trials required for strategy development.
- Compile/contribute to Investigational New Drug Applications (IND) and New Drug Applications (NDA)
Requirements:
- Bachelor’s Degree in related field
- Regulatory Affairs Certification (RAC) highly preferred
- Experience working with medical/IV devices in a regulatory role in industry.
- Experience working directly with notified bodies/FDA is preferred.
- Working knowledge of FDA Regulatory requirements, the EU Medical Device Regulation (EU MDR 2017/745) including technical file requirements (STED or Annex II), and/or with EU In Vitro Diagnostics Directive and Regulations (EU IVDR) required
- Excellent scientific writing and verbal communication skills.
- Ability to identify compliance risks and escalate when necessary.
- Effective interpersonal communication skills – both written and oral
- Experience in 510k or PMA submissions is preferred.
- Experience interacting with NB during Technical File review or Audits is a plus.
- Experience working at FDA with medical devices and/or diagnostics is a plus or a prerequisite depending on the role.
- 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.
