RQM+

Regulatory Affairs Consultant

RQM+

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Job Level

Mid-LevelSenior

About the role

  • 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 (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