Regulatory Affairs Engineer
Company: Innovative Health LLC
Location: Scottsdale
Posted on: February 21, 2026
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Job Description:
Job Description Job Description The Regulatory Affairs Engineer
role is responsible for preparing and submitting the appropriate
documentation for FDA 510(k) submissions and documentation for
other international regulatory bodies. 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; 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; Assist with
label and IFU development and review for compliance before release;
Review promotional material to ensure compliance with applicable
regulations; Implement and maintain unique identifier (UDI)
activities for implementation/compliance ; Assists with FMEA 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 repository. Qualifications:
Minimum of Bachelor's degree in technical field (i.e.
Bioengineering, Electrical Engineering, Mechanical Engineering or
other technical field); Experience and knowledge of FDA 21 CFR Part
820 and 510K submission requirements; Experience and knowledge of
Canadian Medical Device Regulations, MDD, MDSAP and ISO standards
preferred; Minimum of three years medical device experience;
Working knowledge of QMS systems and functionality; Previous 510(k)
submissions; preferred 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.
Keywords: Innovative Health LLC, Avondale , Regulatory Affairs Engineer, Healthcare , Scottsdale, Arizona
