International Regulatory Affairs Specialist II – Electrophysiology (on-site)
Abbott · Plymouth, MN
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Role summary
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.
What they're looking for
- 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
What you'll be doing
- 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
Privacy & handoff
This role links to Abbott's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.