Regulatory Affairs Contractor

This is a fully remote position, open to applicants in United States.

📋 Description

• Submission of FDA 510(k)

• Conduct thorough evaluations of technical documentation (design controls, verification and validation, risk management, labeling, clinical evidence, and relevant software) to ensure completeness, quality, and compliance with regulations

• Execute comprehensive regulatory gap analyses against FDA criteria (21 CFR Parts 807, 820, and relevant FDA guidance documents)

• Author, compile, and submit a complete 510(k) application, including preparation in FDA eSTAR format

• Oversee submission lifecycle activities, including support for Acceptance Review (RTA readiness)

• Coordinate substantive review processes

• Draft and submit responses to FDA requests for Additional Information and engage in interactive review communications

• Update submission content and modules as necessary

• Collaborate cross-functionally to integrate business inputs and ensure alignment throughout the review process

• Provide regulatory guidance to achieve FDA clearance

• Support for EU MDR Technical Documentation

• Conduct readiness assessments for EU MDR in accordance with Notified Body expectations and conformity assessment requirements

• Perform critical evaluations and gap analyses of EU MDR technical files

• Offer targeted recommendations to ensure audit readiness and acceptance by Notified Bodies

• Lead or assist in submissions to secure CE Mark

⛳️ Requirements

• Bachelor’s degree in engineering, life sciences, regulatory affairs, legal, or a related field

• 5-10+ years of global medical device regulatory experience

• Proven track record in preparing, writing, and submitting FDA 510(k) applications from start to finish

• Experience with ophthalmic devices, capital equipment, diagnostic devices, medical device software, and cybersecurity

• Strong understanding of FDA regulations (21 Parts 807, 820), FDA guidance documents, and eSTAR requirements

• Familiarity with Canadian regulations, EU MDR (2017/745), including Class III and Technical Documents Annex II/III

• Demonstrated ability to operate independently as a contractor in a fast-paced environment

• Experience in filing medical device submissions in China and other international markets

• Knowledge of audiology devices

• Experience with artificial intelligence-enabled devices

• Excellent technical writing and documentation abilities

• Capability to translate complex technical information into regulatory submissions

• Detail-oriented with strong organizational skills

• Effective communication skills with both technical and non-technical stakeholders

• Ability to manage multiple deliverables and timelines

🏝️ Benefits

• Competitive salary package

• Opportunities for professional development and growth

• Flexible work environment

• Health and wellness programs

• Collaborative company culture