Regulatory Affairs Specialist-On-site only- Scottsdale, AZ

Innovative Health LLC•Scottsdale, AZ

1d•Onsite

About The Position

The Regulatory Affairs Specialist role is responsible for preparing and submitting the appropriate documentation for FDA 510(k) submissions and documentation for other international regulatory bodies. This role involves managing 510(k) submissions, providing support for international regulatory documents, acting as a liaison with regulatory bodies, reviewing complaints for MDRs, and participating in various project development and audit activities to ensure compliance with applicable regulations.

Requirements

Minimum of Bachelor's degree in technical field (i.e. Bioengineering, Electrical Engineering, Mechanical Engineering or other technical field)
Expert level knowledge of FDA 21 CFR Part 820 and 510K submission requirements
Minimum of five years medical device regulatory experience
Previous 510(k) submissions
Ability to work in a fast paced, collaborative team environment
Ability to handle multiple projects and coordinate cross functional teams
Ability to communicate effectively with management, direct reports and external vendors
Ability to write technical documents (procedures, test methods, protocols and reports)
Ability to recommend technical solutions
Ability to specify regulatory requirements for products
Ability to work with little supervision
Ability to use personal computers including software such as: Word, PowerPoint, Excel, Project and Minitab
Self-starter and highly motivated

Nice To Haves

Experience and knowledge of Canadian Medical Device Regulations, MDD, MDSAP and ISO standards
Sterilization experience

Responsibilities

Responsible for managing and preparing 510(k) submissions to obtain FDA clearance to commercially distribute product
Provides documentation and support for the submission/maintenance of regulatory documents for international regulatory bodies
Acts as the liaison between Innovative Health, the FDA and other international regulatory bodies
Reviews complaints/adverse events for submission of MDRs
Review and approve test protocols/reports and other documentation/information for regulatory submissions from various functional areas and check for errors, legibility, and missing information
Participate in project development teams and review plans, reports, risk management, risk assessments and design reviews associated with product and process projects
Provide regulatory assessments for manufacturing, line extensions, design changes, and validation activities
Participates in internal/external audits and prepares responses to support audit findings or other respective actions related to such audits
Conduct regulatory review and approval of change orders, CAPA/nonconformance, and related project documentation
Review labeling and promotional material to ensure compliance with applicable regulations
Implement and maintain unique identifier (UDI) activities for implementation /compliance
Review clinical documents to ensure that data collection and submission meets global and regional accepted regulatory standards
Assists with DFMEA and PFMEA risk assessments
Maintain and disseminate current knowledge base of existing regulations, standards, or guidance documents and proactively seek and find information to help resolve questions related to assigned projects
Develops and implements company policies and procedures
Assists in archiving regulatory documentation and maintaining related databases