We have been engaged to recruit a Principal Regulatory Affairs Specialist for a premier MedTech innovator specializing in Precision Imaging.  This mid-sized global organization is a top-tier provider of contrast agents and advanced capital equipment injection systems used in over 100 countries.  Known for their “green” radiology initiatives and industry-leading sustainability, they are currently scaling their AI-driven diagnostic platforms and expanding into neonatal and oncology applications.

 

NOTE: this role offers a hybrid work environment, so our client is ONLY considering local candidates as being onsite is required.

 

The Role & Impact: This is a high-impact position focused on both sustaining a market-leading portfolio and steering New Product Development (NPD) through the global regulatory landscape. Main responsibilities to include:

  • Strategic Lead: Drive comprehensive Global Regulatory Strategy, serving as the primary architect for 510(k) submissions and international market access.
  • Agency Engagement: Act as the lead for FDA negotiations, including extensive work with Q-submissions and Pre-subs to de-risk complex clearance paths.
  • Lifecycle Management: Balance a diverse workload that spans the enhancement of existing capital equipment and software as a medical device (SaMD) alongside “ground-up” innovation projects.
  • Subject Matter Expertise: The organization actively encourages continuous learning, providing a clear path to develop and maintain SME specializations in emerging technical domains.

 

Professional Qualifications:

  • Proven track record in FDA Negotiation and a mastery of the 510(k) process.
  • Direct experience with Capital Equipment and/or Medical Device Software.
  • Preferred Technical Depth: While not required, expertise in Cybersecurity, Human Factors, or AI/ML applications is highly valued as the portfolio evolves.

 

Minimum Requirements:

  • Bachelor’s degree plus 7+ years of experience in medical device Regulatory Affairs
  • Demonstrated experience with 510(k), EU CE Marking, and Health Canada submissions
  • Understanding of FDA, EU MDD and MDR, Australia and Canada regulatory framework including how to comply with standards and regulations
  • Experience successfully leading FDA meetings, such as pre-submissions and submission issue request meetings
  • Effective written and verbal communication skills, technical writing and editing skills.
  • Ability to develop clear, concise, and timely oral and written reports, and communicate complex information and regulatory decisions tactfully and concisely to all levels of audiences with varying degrees of familiarity
  • Ability to solve complex problems through the application of critical thinking skills

 

Preferred:

  • RAC Certification
  • Bachelor’s degree in science, engineering or related technical discipline
  • 10+ years or more experience in the medical device industry
  • 10+ years or more working in Regulatory Affairs
  • Advanced level of FDA, Health Canada, TGA, and EU submission experience, including EU MDR
  • International regulatory submission experience, including Japan and China
  • Ability to work effectively in a matrixed environment and influence internal partners to achieve desired business outcomes

 

Compensation & Total Rewards: 

Salary is flexible depending on experience.

Total Rewards:

  • Paid Time Off, Company Holidays & Paid Family Leave – We provide PTO and Company Holidays to help you recharge, relax and do what’s important to you, when it’s important to you. Our 100% paid family leave options for parents, grandparents and eligible family members provide support for growing families as well.
  • Bonus potential up to 15%, based on Company success metrics achieved.
  • Achieve – Beyond competitive compensation, we offer options to help you plan for a financially secure future, including an annual incentive plan and 401k savings plan contributions.
  • Live well – We offer comprehensive benefit options to help protect you along the way, including medical, dental, vision, and life insurance, employer HSA contributions, employee assistance program, short-term disability, etc.
  • Evolve – Through structured on-the-job learning, workshops, seminars, and our tuition reimbursement program, you’ll find many opportunities to grow, personally and professionally.
  • Choose – You won’t find “stuffy” here—whether your position requires a hybrid or in-the-office working arrangement. That means business casual for your attire and flexibility in your schedule, wherever possible.