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Principal Regulatory Affairs Consultant

Principal Regulatory Affairs Consultant

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StarFish Medical has a new Remote opportunity for a Principal Regulatory Affairs Consultant in the US (Eastern Time). Reporting to the Vice President QA/RA in Canada, you will be a member of the Quality Assurance/Regulatory Affairs team. You will work with clients to provide regulatory strategies and submission consulting expertise. In addition, this role will also support product development and manufacturing projects with respect to regulatory requirements to facilitate client and project success.

Are you an excellent influencer and negotiator? Are you very good at collaborating and helping clients to succeed? Can interpret and apply FDA & Health Canada regulations and compliance concepts regarding medical devices? If this sounds like you and this opportunity sounds intriguing, keep reading!

What does StarFish Medical offer you?

The opportunity to work on ground-breaking technology

  • Award-winning culture
  • Competitive compensation
  • Team profit-sharing program
  • Excellent company-paid benefits package
  • Paid vacation and sick leave
  • Monthly All-hands meetings

Job Responsibilities:

  • Partner with the Business Development team (BD) by providing strategic regulatory consulting expertise to prospective clients.
  • Outline the prospect or client’s potential regulatory paths to market, combined with a commitment to get products approved in various regions.
  • Describe a balanced risk approach with potential outcomes of proposed paths in a way the prospects and clients can make their own decisions.
  • Build trusted advisor relationships with prospects and clients
  • Act as a trusted intermediary with regulatory bodies to maintain and build the positive reputation of StarFish and client companies with those agencies.
  • Facilitate meetings with regulatory agencies
  • Prepare and file regulatory submissions for clients (US, Canada, EU).
  • Work collaboratively with project teams to achieve the optimal goal for the client.
  • Assist cross-functional teams with documentation required for regulatory submissions:
  • Review design inputs for regulatory compliance
  • Review design outputs for regulatory compliance (60601, 14971, RoHS, etc.)
  • Work closely with personnel to resolve all issues resulting from review (document corrections, deviations, and clarifications)
  • Provide regulatory input and drive solutions to CAPA Corrective Actions Preventive Actions

Education/Experience:

  • Bachelor’s degree preferably in technical/science field or equivalent combination of education and experience
  • Minimum 10 years of experience in a Regulatory Affairs role with diverse medical device experience (US, EU, Canada)
  • Strategic regulatory consulting experience
  • Extensive experience preparing regulatory strategies and submissions (US, EU, Canada) for complex and novel technology.
  • Extensive knowledge and experience with EU, FDA, and Health Canada medical device regulations
  • Formal Regulatory Affairs Certification desirable
  • Previous experience working for and/or with national agencies a benefit (e.g., ex FDA, HC or notified body)
  • Participation on standards or industry committees is a nice to have.
  • Additional Requirements:
    • Some travel may be required (10%)

Additional Skills:

  • Excellent communication skills (verbal and written); ability to explain complex concepts in simple terms.
  • Strong influencing and negotiation skills.
  • Excellent collaboration and relationship building skills.
  • Ability to read and respond to audiences appropriately.
  • Ability to interpret and apply regulations and compliance concepts
  • Ability to work independently with minimum supervision
  • Experience with IVDD and drug/device combinations is an asset
  • Knowledge and experience with clinical trial requirements and applications is an asset

Don’t meet every single requirement? Studies have shown that women and people of colour are less likely to apply to jobs unless they meet every qualification. At StarFish Medical, we are dedicated to building a diverse, inclusive, and authentic workplace. If you’re excited about this role, but your experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles! Please apply through the StarFish Medical Portal.

If this opportunity excites you and you would love to be part of the innovation, excitement, and award-winning culture found at StarFish Medical, we encourage you to apply!

If you experience any difficulties with the StarFish Medical Job Portal, please reach out to [email protected] with the subject line “Principal Regulatory Affairs Consultant | Job Portal Issue.”

We thank all candidates who apply; however, only those selected for further consideration will be contacted after initial acknowledgment. No phone calls, please.

We look forward to meeting you!

About StarFish Medical 

StarFish Medical is a leading North American contract product development and prototype/low volume manufacturing firm focused on the medical and bio-device spaces with an award-winning culture.  We tend to work on complex electromechanical devices across all medical specialties.  We have over 200 staff located in two main offices in Victoria and Toronto, Canada, and business development staff across the US and have been in business and growing for 23 years.  Our values include innovation, transparency, being aspirational and efficiency. Our job is to enable entrepreneurial medical device companies to improve medical care as their lean med-tech start-up partner assisting them in moving from idea to commercialization with as much founder value intact as possible.  Balancing our innovation mandate with reliable execution is a never-ending challenge.  We need to be consultative and help our clients become valuable and successful, sometimes in ways they didn’t imagine at the beginning, delivering that value in meaningful and powerful ways to them and their investors.  In addition to product development, we also supply intellectual property, regulatory, quality assurance, manufacturing transfer and optimization, supply chain and other complementary services.  We are known for innovation, technical excellence, service-oriented culture, and operational systems.

Contractors

We also seek innovative and dedicated professionals from a wide range of backgrounds to complement our fulltime team on a contracting basis. To apply, please submit a cover letter outlining your interest, availability and rate to the email address listed above.

Co-op Students

Please see our Co-op Placements page for more information.

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