Regulatory Affairs Specialist - Electrophysiology (On-site)
Overview
Lead regulatory strategy for Abbott's Electrophysiology division delivering innovative cardiac therapies. Own end-to-end regulatory submissions across global markets while collaborating with cross-functional teams. Drive compliance excellence and accelerate product launches. This role uniquely combines deep technical expertise with leadership impact in a dynamic matrixed environment.
What You'll Do11
- 1Design and execute regulatory strategies for medical devices supporting atrial fibrillation treatments
- 2Prepare and submit comprehensive regulatory documentation for market authorization
- 3Analyze and implement engineering changes aligned with FDA and international requirements
- 4Review communications ensuring regulatory accuracy and completeness
- 5Maintain updated databases of evolving medical device regulations globally
- 6Interface directly with regulatory agencies to address queries and submissions
- 7Create and approve GTS licenses for product releases
- 8Support QMS and EMS initiatives through regulatory documentation and process improvements
- 9Collaborate with scientific and clinical teams to validate regulatory pathways
- 10Track and distribute regulatory updates to relevant stakeholders
- 11Drive continuous improvement in regulatory submission efficiency and quality
Requirements9
- 1Bachelor's degree in Science or Technical field with 5+ years regulatory experience
- 2Certification: Regulatory Affairs Professionals Society
- 3Proven ability to work in matrixed global environments
- 4Strong analytical skills with attention to detail and deadline management
- 5Excellent written and verbal communication abilities
- 6Master's degree preferred with experience in medical device regulation
- 7Familiarity with FDA and international regulatory frameworks
- 8Experience in cross-functional team leadership and stakeholder management
- 9Ability to thrive in fast-paced healthcare innovation settings
Salary Insight
$51 - $101k per year
Location
Required Skills
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