Regulatory Affairs Expert: Driving Medical Device Compliance
14 hours ago
Company Overview: Baxter, a leading medical innovations company, has been pioneering significant advancements in healthcare for over 85 years.
We create products and therapies that are found in almost every hospital worldwide, in clinics, and in the home. Our mission is to improve outcomes for millions of patients.
Job Summary: As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with international regulatory requirements, guidance, and standards applicable to our products.
About You: We're looking for an experienced professional with a strong background in medical devices and regulatory affairs. Your expertise will help us maintain current knowledge of international regulatory requirements and ensure timely submission of regulatory documents.
Your Key Responsibilities:
- Develop and execute regulatory project plans with direction.
- Identify and elevate key areas of regulatory risk.
- Maintain current knowledge of international regulatory requirements, guidance, and standards.
- Participate as an active team member and provide regulatory advice to project teams.
- Respond to questions from regulatory authorities within strict timelines.
- Compile and submit regulatory documents according to regulatory requirements.
- Maintain and update existing regulatory authorizations.
- Support regulatory activities relating to specific portfolio of products/projects.
- Prepare labeling and review AdProm materials for compliance with local regulations.
- Review advertisement and promotional literature when needed.
- Represent or lead Regulatory Affairs in small project teams.
- Provide guidance to junior team members when needed.
What You'll Need: To be successful in this role, you'll need
- Experience in medical devices.
- A strong understanding of regulatory requirements and standards.
- Excellent communication and problem-solving skills.
- The ability to work independently and as part of a team.
Compensation: The estimated salary for this position is $120,000 - $150,000 per year, depending on location and experience.
Benefits: At Baxter, we offer a comprehensive benefits package, including health insurance, retirement savings, and paid time off.
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