International Regulatory Affairs Specialist II - Electrophysiology (on-site)
$61.3k - $122.7kAbbott
Abbott seeks a Regulatory Affairs Specialist II to support international market entry for electrophysiology devices, primarily in China. The role involves preparing regulatory submissions, evaluating compliance with medical device regulations, tracking timelines, and assessing regulatory impact for product changes. This on-site position in Plymouth, MN requires cross-functional collaboration to advance product registration and ensure adherence to evolving regulatory requirements.
Responsibilities
- Prepare regulatory applications for China market entry and departmental objectives
- Review medical device regulations for submission requirements and update tracking systems
- Evaluate preclinical, clinical, design and manufacturing changes for regulatory strategy
- Communicate submission requirements and timelines to project teams
- Assist with label development and product release approvals for compliance
Requirements
- Bachelor's degree or equivalent qualification
- 2-3 years experience in regulated industry such as medical devices
- Strong written and verbal communication across organizational levels
- Problem-solving skills with strategic thinking ability
- Ability to work collaboratively in fast-paced matrixed environment
- Flexible schedule for meetings with international affiliates
Compensation: $61,300–$122,700 base
Vacancy posted a month ago
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