Employer Industry: Healthcare Innovation and Medical Technology

Why consider this job opportunity:
- Salary up to $143,750
- Opportunity for an annual performance bonus based on individual and corporate performance
- Comprehensive employee benefits including medical, dental, vision, and life insurance
- Participation in the Company’s retirement plan and long-term incentive program
- Generous time off benefits with up to 120 hours of vacation per year
- Flexible remote work opportunity to support work-life balance

What to Expect (Job Responsibilities):
- Collaborate with internal departments to meet regulatory requirements for medical devices
- Develop and implement regulatory strategies aligned with business priorities
- Prepare, review, and submit high-quality regulatory submissions to international authorities
- Coordinate with cross-functional teams to ensure compliance with regulations and standards
- Maintain regulatory files and track compliance-related documentation

What is Required (Qualifications):
- Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; or 3 years with a Master's degree; or a PhD with no experience
- Working knowledge of domestic and international regulatory guidelines and policies
- Experience with pre- and post-market medical device submissions, including EU Technical Files
- Strong verbal and written communication skills with diverse audiences
- Proficiency in MS Word, Excel, Adobe, and PowerPoint

How to Stand Out (Preferred Qualifications):
- Class III medical device experience preferred
- Technical, scientific, or engineering background or experience is advantageous
- Ability to outline sound regulatory strategies in alignment with business priorities
- Experience with regulatory submissions specific to MDR
- Strong organizational skills with the ability to manage multiple projects simultaneously

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