Regulatory Specialist II

Irvine, California
Quality – Regulatory /
Full Time /
On-site
About Us
Fluxergy is a rapidly growing biomedical company on the cutting edge of laboratory testing. We're developing a true multi-modal point of care device, the kind of which has never been conceived, and we'd love to have you as part of the team.
 
Fluxergy’s technologies span many markets in addition to healthcare, including veterinary, food safety, and wellness industries. We are seeking motivated team members who are willing to commit themselves and their time to improving and decentralizing laboratory infrastructure to the places that need it most.
 
With its roots in engineering, Fluxergy prides itself on critical thinking and solving problems pragmatically, from a modular and systems-level approach. We believe that open and clear communication along with the ability to adapt to changing situations and working outside of your comfort zone is paramount to our success. The ideal candidate for this position should embody these philosophies as well as be resourceful, trustworthy, and have a deep desire to constantly learn.    

Our product: https://vimeo.com/845429891

About the Role
This is an opportunity to be a part of a small but passionate team with a big impact! You will be involved in all things Regulatory at Fluxergy, responsible for ensuring our processes, procedures, and product meet ISO13485 and FDA requirements. You will play an important part in the company's long-term strategy. We are looking for someone that is eager to learn and ready to collaborate. Sound interesting? We’d love to hear from you!
 
Team Culture
- Open-minded
- Communicative
- Problem Solvers
- Positive
- Self-starters

What You'll Do

    • Support or lead regulatory submission for US FDA (Q-Sub, 510k), EU (CE-Marking), and/or other regulatory jurisdictions.
    • Prepare and maintain technical documentation for FDA 510(k), CE-IVD, and other regulatory jurisdictions.
    • Conduct research to identify and interpret any new/updated regulatory requirements for company products and processes.
    • Perform regulatory assessments for vigilance reporting; support adverse event reporting, field actions, and other post-market surveillance activities.
    • Maintain UDI data in US GUDID and EU EUDAMED.
    • Review and update labeling for compliance to all applicable regulatory requirements.
    • Review promotional materials for regulatory compliance.
    • Support third-party regulatory audits.
    • Collaborate cross-functionally (e.g., Quality Assurance, Research & Development, Product/Program Management, Marketing) to ensure regulatory requirements are met and collect and coordinate information regulatory documentation for regulatory submissions.

What You'll Need to Have

    • Experience with Technical Documentation and Design Dossier regulatory submissions for US FDA (Q-Sub, 510k) and/or EU CE-Marking. Medical device is required; IVD is a plus.
    • Working knowledge and understanding of regulatory requirements for both products and processes in US (FDA 21CFR) and EU (MDR and/or IVDR).
    • Support international registrations including compiling technical documentation for submissions and satisfying requirements for distributors/importers.
    • Experience in medical device – preferably IVD – regulatory labeling, including Instructions For Use (IFUs) and product labels.
    • Effective writing skills and ability to use common software tools to develop and edit documents, procedures, reports.
    • Effective communication and strong organizational skills.
    • High degree of initiative with the ability to work independently with minimal supervision.
Interview Process  
Our interview processes my differ slightly from role-to-role; however, most of our interviews will follow a similar pattern: 

- Recruiter Interview  
- Hiring Manager interview 
- On-site Interview
- Decision    

We are an early-stage company and may change our interview process from time-to-time, but our hope is everyone who interviews with us has a positive experience, even if an offer isn’t presented.  

Fluxergy Benefits
Medical/Dental
- 99% medical benefit premiums (gold and platinum level) are paid by Fluxergy and covers you, your partner, and/or dependents
- 100% dental and vision (PPO) premiums paid for the Fluxergy employee, partner, and/or dependents
- 100% Life Insurance premiums paid for employee

Work/Life Balance Minded PTO
* 15 paid vacation days
* 2-week paid winter break
* 7 company paid holidays
* 5 paid sick days

Promote from within - many of our current leaders started their career with Fluxergy!
* Wear lots of hats / accelerate your career growth!
* We are a flat organization by design – lots of visibility!

Salary: $85,000- $95,000

Additional Information
Fluxergy is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, marital status, age, disability, national or ethnic origin, military service status, citizenship, or other protected characteristic. 

Fluxergy participates in the E-Verify program. Please click hereherehere for more information.