Fractional Senior Regulatory Affairs Specialist

The Role

Blackrock Neurotech is seeking a Contract Senior Regulatory Affairs Specialist to provide hands-on regulatory support across our medical device programs. This is a part-time/fractional opportunity, expected to require up to 25 hours per week, with flexibility based on business needs. In this role, you'll evaluate product and labeling changes, support audit activities, and help develop procedures within our existing quality management system.

You'll bring strong working knowledge of ISO 13485 and ISO 14971, sound regulatory judgment, and the ability to independently move work forward. Experience developing quality system processes for clinical trial sponsorship would be particularly valuable as we build out this capability.

• Prepare standard operating procedures and work instructions and integrate them into Blackrock's existing quality management system
• Evaluate product changes to determine their regulatory impact on existing device clearances and document the assessment and rationale
• Provide regulatory guidance and deliverables for device development projects
• Support sterilization audits, cleanroom audits and inspections, and internal audits
• Review labeling changes and associated deviations for regulatory impact and alignment with applicable requirements
• Partner with Regulatory, Quality, Clinical, and Engineering colleagues to resolve questions and complete assigned deliverables

• Senior-level regulatory affairs experience within the medical device industry, with the ability to independently assess issues and provide practical guidance
• Strong working knowledge and demonstrated application of ISO 13485 and ISO 14971
• Experience evaluating device changes for regulatory impact, including effects on existing clearances
• Experience drafting and maintaining SOPs, work instructions, and other controlled documents within an established quality management system
• Familiarity with audit support, labeling review, and deviation processes
• Strong technical writing, attention to detail, and the ability to manage multiple priorities and meet project deadlines

Contract Details:

• Location: Remote, with travel to Blackrock Neurotech's headquarters in Salt Lake City, Utah, as needed
• Engagement: Fractional, part-time contract
• Duration: Approximately 3 months