Procurement/Supply Chain - Regulatory Affairs Contractor#26-18287 $100 per hour New York, NY Onsite Job Description Requisition Details # of positions

Needed:

1

Job Title/Job Description:

RegulatoryAffairs Contractor Essilor 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.

GENERAL FUNCTION

Essilor 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

EEO:

"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."