Regulatory Affairs Specialist

Mira was inspired by thousands of women who are struggling with fertility journey. We create our new products with such families in mind to provide them with much-needed support and accuracy.

As we’re growing, we have many wonderful ideas about how to help our community lead happier, healthier lives. Today is your chance to join the passionate team of professionals and help us to take a step closer to our mission.

As a resident Regulatory Affairs Specialist specifically focusing on FDA, you will serve as a key advisor and strategic consultant, assisting with FDA clinical trial filings, answering FDA’s questions, and providing strategies on product registration and the plan of clinical trials. You are a critical pillar of compliance efforts, as you will ensure FDA compliance with regulatory requirements at each stage of product development and clinical trial timelines.

Requirements:

  • 5+ years experience as regulatory affairs specialist or equivalent, with 3+ years of experience working with FDA clinical filings;
  • Must have done FDA submission process:
  • 510k
  • PMA
  • Must know how to research and categorize products with FDA;
  • Must have worked on responses of MDR by him or herself;
  • Have done marketing claim reviews;
  • Must have talked with FDA on the calls;
  • Knows how to source outside registration agencies for EU, UK, AU, CA registrations.

Nice to have:

  • International registration experience in EU, UK, AU, or CA
  • Clinical trial submission and management with FDA

Responsibilities:

  • Ensure all regulatory requirements are met throughout the product development lifecycle
  • Design and complete FDA clinical trial
  • Prepare 510(k) regulatory applications and 510(k) letters to file to secure/maintain marketing approvals
  • Review advertising and marketing materials, ensure appropriateness and compliance to FDA regulatory requirements
  • Responsible for timely registration of the facility
  • Maintaining current knowledge of FDA and international regulation and standards, as applicable to company products
  • Answering FDA’s questions
  • Dealing with FDA MDR cases
  • Evaluating risks for other international markets, such as EU, UK, Australia, and Canada

What we offer:

  • 100% remote work with purpose;
  • Competitive salary and transparent, achievable bonus remuneration;
  • Open career paths for those who are willing to grow and develop us;
  • Generous benefits package;
  • Educational options;
  • Flexible schedule;
  • Limitless ways to make changes;
  • Lots of fun