Role OverviewThe Principal Specialist, Regulatory Affairs (Medical Devices) is responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory approval, and preparing global submissions.
What You Will Do
Develop and implement medical device regulatory strategies, prepare submissions, and provide leadership to product development teams for regulatory issues.
Why It Might Be a Fit
This position requires a minimum of 8 years related work experience, excellent oral communication and technical writing skills, and advanced knowledge of product life cycle and international regulatory competency.
Requirements
- Bachelor's Degree in science, math, engineering, life sciences or related discipline
- Minimum 8 years related work experience
- Medical device or Combination Product regulatory experience preferred
- RAPS Regulatory Affairs Certifications (RAC)-Medical Devices - Upon Hire preferred
Benefits
- Generous Paid Time Off (PTO)
- Global Career Opportunities
- Inclusive & Collaborative Culture
- Recognition & Rewards
- Health insurance
- Retirement plan
- Learning budget
- Parental leave
- Wellness programs
- Visa/relocation assistance
- Remote flexibility
- Bonus/commission
- Paid holidays
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