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Principal Regulatory Affairs Consultant
2 weeks ago
**StarFish Medical** has a new opportunity for a **Principal Regulatory Affairs Consultant. **This role will be** remote for US applicants in the ET zone and hybrid for applicants in Toronto, ON, or Victoria, BC. **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.
What does** **StarFish Medical** offer you?
- The opportunity to work on cutting-edge technology.
- An Award-winning culture.
- Competitive compensation.
- Profit-sharing program.
- Excellent company-paid benefits package.
- Paid vacation and sick leave.
- Monthly All-hands meetings.
- Active social committee.
- 50% BC Transit in Victoria / TTC cost-sharing in Toronto.
- Both locations offer shower facilities for midday runs or biking to work; Victoria offers Galloping Goose access close by, while Toronto offers a Bike Share station within a 5-minute walk to the Office.
- Both locations offer free parking on-site or around the premises.
**You will**:
- 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 the documentation required for regulatory submissions:
- Review design inputs for regulatory compliance.
- Review design outputs for regulatory compliance (60601, 14971, RoHS, etc.).
This is an abridged version of the responsibilities; kindly review the full Job Description (StarFish Medical Career Page) to understand the full scope of duties.
- Bachelor’s degree preferably in technical/science field or equivalent combination of education and experience.
- Minimum 10 years 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 is desirable.
- Previous experience working for national agencies a benefit (e.g., ex FDA, HC or notified body).
- Additional Requirement:
- Some travel may be required (10%)
**These skills and abilities will help you thrive**:
- 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 work independently with minimum supervision.
- Experience with IVDD and drug/device combinations is an asset.
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
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 with an award-winning culture focused on the medical and bio-device spaces. 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 dev
