International Regulatory Affairs Specialist I – Electrophysiology (on-site)
$50,700–$101,300 year
On-site · Plymouth, Minnesota, United States
Job Summary
International Regulatory Affairs Specialist I role focuses on assistance in preparing regulatory applications for Asian geographies, providing regulatory input to product lifecycle planning, developing multi-country regulatory strategies, and supporting regulatory assessments for international geo areas. On-site at Abbott’s Plymouth, MN location, responsibilities include determining submission and approval requirements, reviewing communications to ensure regulatory standards are met, and interfacing with regulatory agencies when needed. The position supports product release processes, and ensures compliance with QMS, EMS, and other regulatory requirements, while collaborating across divisions and with stakeholders to meet regulatory objectives. Preferred qualifications include a science/technical degree, cross-division experience, and additional language skills; regulatory affairs certification is a plus. The base pay range is $50,700 - $101,300, with potential variances by location per policy.
Required Qualifications
- Bachelor’s Degree or an equivalent combination of education and work experience
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Ability to work in a highly matrixed and geographically diverse business environment
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Multitasks, prioritizes and meets deadlines in timely manner
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