Senior Regulatory Affairs Spec
$92,000–$138,000 year
On-siteMounds View, Minnesota, United States
Job Summary
Prepare US and EU MDR submissions for new products and changes to ensure timely market approval for pacemakers, defibrillators, and software as a medical device. Develop worldwide regulatory strategies, review labeling and documentation for existing devices, and negotiate approvals with international agencies. Provide ongoing support to project teams by interpreting global directives, harmonized standards, and technical principles for regulatory compliance. Maintain product files, assist with license renewals and design change notifications, and participate in cross-functional meetings to plan strategies and define target markets. Work under general supervision following established procedures while independently determining approaches for submission issues.
Required Qualifications
- Bachelor's degree in a technical discipline
- Minimum 4 Years of medical device regulatory experience with Bachelor's degree
- Minimum 2 Years of medical device regulatory experience with an advanced degree
- Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and PMDA), and working with cross-functional project teams
- In depth experience with FDA requirements, FDA guidance documents, EU Medical Device Regulation, IEC 62304, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
- Working knowledge of SaMD and SiMD
- Positive track record engaging with regulators
- History of successful device submissions
- Strong negotiation skills and written/oral communication skills
- Strong organizational skills and time management skills
- Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
- Ability to work independently and under general direction only
- Computer skills; MS Office, MS Project, Adobe Acrobat and Agile
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment
Desired Qualifications
- Master of Science Degree
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