Regulatory Affairs Specialist
Based in Salt Lake City, Utah
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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:
Responsible for activities which lead to compilation, submission, and maintenance of domestic and international regulatory approval and clearance to market medical devices. Responsible for communicating regulatory requirements throughout a product’s lifecycle to ensure awareness and to help establish regulatory strategy.
- • Bachelor’s degree or higher, ideally in Engineering, Biological Sciences, 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, 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.
• Ability for assessment of significant device changes on clinically cleared products.
• Ideal candidate should have strong knowledge of ISO 13485 (Quality Management Systems), MDSAP and medical device regulation for Canada and Australia.
• Regulatory knowledge for China, South Korea, and Israel are a plus.
• Ideal candidate should be current on relevant standards to support product compliance, that include, but not limited to:
- o ISO 10993 (Biological evaluation of medical devices – Biocompatibility)
o ISO 11135 (Sterilization of health products)
o ISO 14971 (Risk Management)
o IEC 60601 (Product Safety Standards – EMC Testing)
- • Ideal candidate must demonstrate effective communication skills across all organizational levels.
• Ideal candidate can act independently to determine methods to define problems, interpret data, establish facts, and draw valid conclusions.
• Ideal candidate should demonstrate being detail oriented with strong organizational skills.
• Ideal candidate should demonstrate strong interpersonal skills with willingness to be held accountable for deliverables.
- • Responsible for activities for the compilation, submission, and maintenance for regulatory approval on medical devices that include: CE Mark, 510(k) premarket notifications (traditional, special, and abbreviated), post-approval reports, and technical files.
• In a cross functional team, communicating FDA and global regulatory requirements throughout a product’s lifecycle to ensure awareness and to help establish regulatory strategy, classification, and applications.
• Support to generate and review regulatory compliance test plans to support submissions. This may include coordinating regulatory testing with external laboratories.
• 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.
• Performs other assignments as required by the management.
PHYSICAL AND OTHER REQUIREMENTS
- • Strong organization skills and attention to detail
• Excellent oral and written communication skills
• Excellent time management skills, thorough and detail oriented
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. Applicants must currently be authorized to work in the United States on a full-time basis.