Regulatory Affairs Contractor

Engagement Details
Type: Contractor (Hourly, Time and Materials)
Expected duration: 6-12 months (depending on FDA review timelines)
Start: Immediate
Workload: Flexible estimate 20- 40 hours per week.
Location: Remote

GENERAL FUNCTION

Client is seeking an experienced Regulatory Affairs contractor to support the preparation and submission of a US FDA 510k and the development of global regulatory documentation, including EU MDR Class IIa readiness and technical documentation.

This role is a hand-on, execution-focused contractor position responsible for reviewing technical documentation, ensuring regulatory compliance, authoring submission materials, and supporting documentation regulatory strategies across US, EU and global markets. The contractor will work cross-functionally with R&D, clinical, project management and quality teams.

MAJOR DUTIES AND RESPONSIBILITIES
• FDA 510(k) submission
o Conduct comprehensive review of technical documentation (design controls, V&V, risk, labeling, clinical evidence, and software as applicable) to ensure completeness, quality, and regulatory compliance
o Perform detailed regulatory gap assessments against FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents)
o Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format,
o Lead submission lifecycle activities, including:
o Acceptance Review support (RTA readiness)
o Substantive Review coordination
o Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications
o Updating submission content and modules as required
o Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process.
o Provide regulatory leadership through FDA clearance.
• EU MDR Technical Documentation Support
o Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements.
o Perform critical review and gap analysis of EU MDR technical file
o Provide targeted recommendations to ensure audit-readiness and Notified Body acceptance
o Lead or support submission to obtain CE Mark
• Health Canada submission
o Perform regulatory strategy and classification confirmation, including Medical Device License (MDL) pathway and Summary of Safety and Effectiveness (SSOR) readiness assessment
o Author and compile complete Canadian submission dossiers in accordance with Health Canada structure and requirements.
o Support review process, including preparation, and coordination of responses to Health Canada information requests.
• Global Regulatory Strategy and Advisory
o Develop and maintain a harmonized global regulatory dossier to enable efficient market expansion.
o Define and implement documentation reuse strategies across justification, including identification of gaps, risks, assumptions, and sequencing.
o Author a comprehensive global strategy document outlining pathways, timelines, and key risks.
o Provide ongoing regulatory guidance and advisory support to the Business cross-functional teams to ensure compliance and execution alignment.
o Lead or support global regulatory submissions as needed.

BASIC QUALIFICATIONS
• Bachelor's degree in engineering, life sciences, regulatory affairs, legal or a related field
• 5-10 years+ of global medical device regulatory experience
• Proven experience preparing, writing and submitting FDA 510k submissions (end to end)
• Experience with ophthalmic devices, capital equipment, diagnostic devices, software in medical devices, cybersecurity
• Strong working knowledge of:
o FDA regulations (21 Parts 807, 820)
o FDA guidance documents and eStar requirements
o Experience with Canadian regulations, EU MDR (2017/745) including Class lla, Tech docs Annex ll/lll
• Demonstrated ability to work independently as a contractor in a fast-paced environment


PREFERRED QUALIFICATIONS
• Experience filing medical device submissions in China and other countries
• Experience with audiology devices
• Experience with artificial-intelligence enabled devices

Skills & competencies
o Strong technical writing and documentation skills
o Ability to translate complex technical information into regulatory submissions
o Detail-oriented with strong organization skills
o Effective communicator across technical and non-technical stakeholders
o Ability to manage multiple deliverables and timelines