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Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
European Union Regulatory Affairs, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
This position is intended to provide Regulatory Affairs support to Boulder iQ, LLC. This position supports full, ongoing compliance to all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards.
Duties and Responsibilities
Perform Pre-Market U.S. FDA submissions (510(k) and PMA) in accordance with the product plan.
Provide feedback and recommendations to design teams regarding deciding when to submit a 510(k) for a change to an existing medical device.
Prepare European Union Technical Files and International Regulatory Submissions.
Coordinate Import/Export/Customs activities.
Evaluate all sources of incoming customer information, identify, investigate and document Customer Complaints, perform trend analysis and maintain all records.
Determine the Medical Device Reportability of all identified Customer Complaints, take appropriate action and maintain all records.
Coordinate all Mandatory Field Notifications, Engineering Change Orders, and Correction and Removals, take appropriate action and maintain all records.
Interact closely with Customer Service, Service, Repair, Research and Development, Quality Assurance, Regulatory Affairs and Sales to facilitate required action.
Perform Corrective and Preventive Action activities.
Perform Internal Audits and External Supplier Audits.
Coordinate U.S. FDA remediation activities.
Prepare Management Review Meeting presentations.
Attend all department and company-wide team meetings as needed.
Other duties as assigned.
Comply with all applicable U.S. Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations and standards.
Bachelor Degree or higher required.
Three (3) or more years of hands on experience performing Regulatory Affairs support activities in a U.S. FDA regulated environment.
Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807) and U.S. FDA import/export/customs regulations.
Deep knowledge of international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive and Canada Medical Device Regulations).
Excellent leadership, communication, collaboration, team work and interpersonal skills.
Superb ability to effectively communicate with staff members and business partners at all levels of the organization (both internal and external).
Excellent computer and internet search skills.
Strong ability to multi-task and to meet business deadlines.
Excellent organizational skills with an ability to think proactively and prioritize work.
The position requires the ability to perform the following physical demands and/or have the listed capabilities.
The ability to sit up 75-100% of applicable work time.
The ability to use your hands and fingers to feel and manipulate items, including keyboards, up to 100% of applicable work time.
The ability to stand, talk, and hear for 75% of applicable work time.
The ability to lift and carry up to ten pounds up to 20% of applicable work time.
Close Vision: The ability to see clearly at twenty inches or less.
Occasional (up to 25%) travel may be required based on business need.
Internal Number: 20200512-1
About Boulder IQ
Boulder iQ is an expert contract consulting firm offering design engineering, development and turnkey manufacturing for consumer, high-technology and medical products, and complete services for regulatory and quality management systems in the medical device and in-vitro diagnostic (IVD) industries.
In its design engineering work, Boulder iQ specializes in innovation, human factors and system design, from concept through manufacturing. Services include guidance for medical technology companies worldwide on global medical device clinical regulations (ISO 13485:2016 certification through Boulder BioMed). Additional services include regulatory consulting for U.S. FDA classification, submissions for EU MDR technical documentation, clinical evaluation reports, remediation activities, and regulatory affairs/quality assurance outsourcing.
Boulder iQ is based in Boulder, Colorado.