Senior Regulatory Affairs Specialist

Job Summary

A company is looking for a Senior Regulatory Affairs Specialist.

Key Responsibilities:

• Provide global regulatory requirements as an input to new product development and sustaining teams
• Prepare and coordinate regulatory strategies
• Review test protocols and reports

Required Qualifications:

• Bachelor's degree required
• Minimum 5 years' experience in regulatory affairs or a combination of medical device technical design support and/or an advanced degree may be considered as partial fulfillment of experience
• Successful US or EU device certification is required
• Proven ability to contribute creative, practical strategies to achieve business objectives
• Experience with SAP strongly preferred