Based in Salt Lake City, Utah
To apply, please submit your resume and cover letter to: email@example.com
Blackrock aims to provide Best of Class approved neurosciences tools to the research community to push the boundaries of human applications. We are a high-tech company that continuously innovates to empower researchers to better understand the brain.
We also aim to be the provider of implantable neural interfaces to restore function to people with neurological disorders. Blackrock already delivers some of the most critical components of leading BCI set-ups. We spend every day building technology that will benefit patients suffering from paralysis disorders, neurological diseases (ALS, Alzheimer’s, Parkinson’s), and neural dysfunctions (epilepsy, brain trauma).
Join us in the challenge and contribute the following:
Blackrock is seeking a Regulatory Affairs specialist who is responsible for activities which lead to compilation, submission, and maintenance of domestic and international regulatory approval and clearance to market medical devices. The Ideal candidate will communicate regulatory requirements throughout a product’s lifecycle to ensure awareness and to help establish regulatory strategy.
- Develop Bachelor’s degree or higher in STEM (Science, Technology, Engineering and Mathematics, Regulatory Affairs), or equivalent
- Ideal candidates should have Regulatory Affairs Certification (RAC) for medical devices, but not required.
- Minimum of 4 years of regulatory experience in the medical device industry that may include: compilation, submission, and maintenance of 510(k) premarket notifications, EU MDR, Health Canada, Therapeutic Goods Administration, NMPA, Notified Bodies and other international regulatory filings for class II/III medical devices.
Specific Skills/Competencies Desired
- Demonstrate a working knowledge of FDA 510(k) premarket notification requirements through successful submissions.
- Participation in FDA, MDSAP and notified body audits.
- Prepares and maintains technical files as necessary to obtain and sustain product approvals.
- Ideal candidate should be current on relevant standards to support product compliance, that include, but not limited to:
- ISO 10993 (Biological evaluation of medical devices – Biocompatibility)
- ISO 11135 (Sterilization of health products)
Essential Job Duties
- Communicating FDA and global regulatory requirements throughout a product’s lifecycle to ensure awareness and to help establish regulatory strategy, classification, and applications.
- Maintain state of the art knowledge of medical device regulatory requirements, standards, and guidance documents. Support in maintaining regulatory documentation databases.
- Assist in the review of product labeling and promotional materials for compliance with cleared claims and with applicable regulations.
- Maintain registration information (license numbers, expiration dates, etc.), support post-market surveillance and vigilance regulatory activities, and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.
- —A schedule with some flexibility
- —Access to a diverse, multicultural and caring family-like team
- —The challenge of fitting various employee and company organized events (hiking, biking, football (soccer), volleyball, gaming…) into your working day
- —A free bike/ski helmet
- —Fantastic facilities with showers, bike parking and a direct view of trails up the Wasatch Front
- —Medical, vision and dental insurance
- —Life and AD&D insurance
- —Short and long-term disability insurance
- —Flexible vacation/sick leave
- —Paid maternity, paternity and adoption leave
- —401(k) with generous matching and immediate vesting
- —An opportunity for personal development and a career that will impact other people’s lives in a fundamental way
- —A company that ensured continued employment of all employees throughout COVID while diligently focusing on the safety and health of every team member.
Blackrock Microsystems is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to color, disability status, national origin, race, religion, sex, or age. However, applicants must be currently authorized to work in the United States on a full-time basis.