International Regulatory Affairs Specialist II – Electrophysiology (on-site)
$61,300–$122,700 year
On-sitePlymouth, Minnesota, United States
Job Summary
Prepare regulatory applications and review documentation for international geographies, primarily China, to ensure product compliance. Evaluate preclinical, clinical, and manufacturing changes for submission strategies, track deliverables against timelines, and communicate approval requirements to project teams. Act as the regulatory representative for guidelines, assist in label development, and support product release processes while maintaining Quality Management Systems standards. This role supports Abbott's Electrophysiology business in advancing heart disease treatments, requiring a Bachelor's degree and 2-3 years of regulated industry experience. The position offers a salary range of $61,300.00 – $122,700.00 with a standard work shift in Plymouth, MN.
Required Qualifications
- Bachelor's degree (or equivalent)
- 2-3 years' experience in a regulated industry (e.g., medical products, nutritionals)
- Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Flexible schedule to attend meetings as needed with affiliates in other geographies
- Strong problem-solving skills and ability to think strategically and see the big picture
- Yes, 5 % of the Time
Desired Qualifications
- Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, clinical, or related area
- Higher education may compensate for years of experience
- Bachelor's degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields
- Master's degree
- Experience with medical device industry
- Experience working with NMPA (CFDA) or other international regulatory parties
- Chinese/Mandarin speaking candidate
- Experience working in a broader enterprise/cross-division business unit model
- Adaptable with the ability to switch priorities and accomplish all tasks
- Process oriented
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
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