Sr. RA Specialist

Regulatory Affairs Specialist - West Chester, PA

Join our dynamic team in West Chester, PA, where you will play a critical role in ensuring the successful market distribution of medical devices across the globe. As a Regulatory Affairs Specialist, you will be at the forefront of preparing and submitting regulatory documentation to support both new and modified medical devices in the US, Canada, EU, and beyond. Collaborate with cross-functional teams to drive compliance and innovation in the medical device industry.

Key Responsibilities

• Prepare and review regulatory submissions for various markets.
• Ensure compliance with FDA and other international regulatory bodies.
• Maintain and update regulatory databases and documentation.
• Provide regulatory input throughout the product lifecycle.
• Conduct risk-benefit analysis for regulatory compliance.
• Communicate effectively with internal and external stakeholders.
• Participate in professional associations and industry groups.
• Ensure adherence to Health, Safety, and Environmental practices.

Requirements

• Bachelor's Degree in Science or Engineering.
• 4-6 years of regulatory experience in the medical device industry.
• Excellent written and oral communication skills.
• Strong organizational skills and attention to detail.
• Knowledge of clinical research, quality, and regulatory requirements including GxPs (GCPs, GLPs, GMPs).

Preferences

• Experience with 510(k) submissions and international regulatory processes.
• Ability to handle multiple tasks efficiently.
• Participation in industry/trade groups and standards organizations.

Ready to make a difference in the medical device industry? Apply now to join our team in West Chester, PA, and be part of a company committed to innovation and excellence.