Regulatory Affairs Specialist 4

Intuitive • Sunnyvale, CA

2d

About The Position

Primary Function of Position The Senior Regulatory Affairs Specialist serves as the primary point of contact for regulatory strategy and execution of projects involving complex electromechanical, software controlled robotic systems, instruments and accessories, SaMD and advanced imaging systems. The Senior RA Specialist works across the organization and liaises with global regulatory counterparts on a wide range of products including capital equipment, instruments and accessories (single use or re-usable), and software, focusing on supporting ongoing changes and continuous improvement to these products.

Requirements

• Minimum of 8 years experience working in a medical device company performing regulatory submissions and technical documentation (can be in combination with a Masters in Regulatory Science or Master of Engineering, Biomedical Engineering)
• Experience working with cross-functional teams including engineering, manufacturing, quality, marketing, clinical, labeling, packaging, etc.
• Working understanding of FDA regulations
• Ability to work with cross functional project teams and understand complex products
• Ability to work in a fast-paced environment and handle multiple projects simultaneously
• Strong verbal and written communication skills, proven ability to translate technical documentation into effective internal documentation, and regulatory submissions
• Ability to review and provide critical feedback on design documentation
• Strong interpersonal and project management skills
• Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred.

Nice To Haves

• Previous regulatory submissions experience with complex electromechanical, software controlled robotic systems, SaMD or advanced imaging systems preferred.

Responsibilities

• Support product engineering and manufacturing teams on regulatory issues, including review of design input, risk management and test documentation
• Evaluate changes to products including changes to design, material, labeling, packaging, manufacturing process, and facility
• Assess the impact of the product/process changes and determine regulatory pathway for US markets
• Present regulatory strategy and status in internal group settings
• Gather information from international counterparts for ROW regarding the impact of changes and work with international counterparts to coordinate global regulatory submissions/approvals
• Prepare internal documentation, and prepare and submit regulatory filings including non-filing justifications (NFJ) and 510(k)s
• Provide oversight of third party agency testing (UL, EMC, biocompatibility, sterilization) as required
• Perform other duties as required

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level