Regulatory Affairs Senior Contractor

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

Temporary Contractor Role

Duration: 12 months

Must be local to Pleasanton, CA

The Senior Regulatory Affairs Contractor will support activities related to our client's US-Class III FDA PMA device.

• Sustaining activities in support of a series of change assessments, some of which will equate to submissions.
• Inform and evaluate any changes.
• Write submissions (manufacturing/process/supplier type of sustaining changes).
• Manage and answer questions (if any) the regulator may have.
• Independently review cross-functional documentation (COs/test documents/other).

• Bachelor’s Degree in related field
• Regulatory Affairs Certification (RAC) highly preferred
• Experience working with medical 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 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. 

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.

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