Senior Regulatory Affairs Specialist

Description:

• BA/BS degree
• 5-7 years regulatory experience in Medical Device industry (Class III devices REQUIRED)
• Experience with submissions to European regulatory authorities and FDA
• Working knowledge of ISO 13485, GMP, MDR requirements.

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  Required Knowledge, Skills and Abilities

• Good working knowledge of ISO 13485 guidelines, standards, GMP, MDR requirements.
• Advanced degree in a scientific discipline (engineering, physical/biological or health sciences) or in Regulatory Affairs, preferred
• Work well in cross-functional teams, independent yet passionate, good communication skills and a team player
• Demonstrate a continuous desire to identify, learn and understand up-to-date regulatory requirements, best practices, and trends and apply with practical solutions
• Analytical and data-driven
• Maintain extremely high attention to detail and follow through
• Effective organizational skills
• Proficient in Microsoft Office including Outlook, PowerPoint, Word, and Excel