Regulatory Affairs Associate

Innovative Health•Scottsdale, AZ

About The Position

The Regulatory Affairs Associate role is responsible for assisting with preparing and submitting the appropriate documentation for pre-market submissions (i.e. FDA 510(k) submissions, Health Canada Device License Applications). This role also supports post-market regulatory compliance activities.

Requirements

Minimum of Bachelor's degree (preferably in (i.e. Engineering, Biological Sciences, or other technical field) or equivalent education, training and experience
Minimum of one (1) year medical device regulatory and/or quality experience
Basic knowledge of FDA 21 CFR Part 820, ISO13485, and 510(k) submission requirements preferred
Basic knowledge of Canadian Medical Device Regulations, MDD, MDSAP and ISO standards preferred
High degree of initiative, be able to balance a variety of tasks, and with strong organizational abilities
Strong commitment to quality, accuracy and detail
Excellent oral & written communications skills
Excellent interpersonal skills are required, due to the numerous internal customers with varying and unique requirements/ priorities. Must understand the nature of the work and the impact it has on the organization.
Ability to work in a fast paced/entrepreneurial team environment
Proficient in computer applications (i.e. Microsoft Office, Word, PowerPoint, Excel, etc.)

Nice To Haves

Basic knowledge of FDA 21 CFR Part 820, ISO13485, and 510(k) submission requirements preferred
Basic knowledge of Canadian Medical Device Regulations, MDD, MDSAP and ISO standards preferred

Responsibilities

Assisting with responses to deficiency letters and other requests for documentation for submissions.
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
Assist with the development of labeling and ensure compliance with applicable regulations
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
Conduct regulatory review and approval of change orders and related project documentation
Implement and maintain unique identifier (UDI) activities for compliance
Assists with PFMEA risk assessments
Assists in archiving regulatory documentation and maintaining related databases
Participate in internal and external audits
Assist with other Regulatory projects and activities as required.