Regulatory Affairs Specialist

Job Description

Job Summary:

• 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:

• 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.
• Perform detailed regulatory gap assessments a Products FDA requirements (21 CFR Parts 807, 820, and applicable FDA guidance documents).
• Author, compile and deliver a complete 510k submission, including preparation in FDA eSTAR format, Lead submission lifecycle activities, including:
• Acceptance Review support (RTA readiness).
• Substantive Review coordination.
• Drafting and submission of responses to FDA requests for Additional Information, Interactive review communications.
• Updating submission content and modules as required.
• Interface cross-functionally to incorporate Business inputs and ensure alignment throughout the review process.
• Provide regulatory leadership through FDA clearance.

EU MDR Technical Documentation Support:

• Conduct EU MDR readiness assessment aligned with Notified Body expectations and conformity assessment requirements.
• Perform critical review and gap analysis of EU MDR technical file.
• Provide Client recommendations to ensure audit-readiness and Notified Body acceptance.
• Lead or support submission to obtain CE Mark.

Health Canada submission:

• Perform regulatory strategy and classification confirmation, including Medical Device License (MDL) pathway and Summary of Safety and Effectiveness (SSOR) readiness assessment.
• Author and compile complete Canadian submission dossiers in accordance with Health Canada structure and requirements.
• Support review process, including preparation, and coordination of responses to Health Canada information requests.

Global Regulatory Strategy and Advisory:

• Develop and maintain a harmonized global regulatory dossier to enable efficient market expansion.
• Define and implement documentation reuse strategies across justification, including identification of gaps, risks, assumptions, and sequencing.
• Author a comprehensive global strategy document outlining pathways, timelines, and key risks.
• Provide ongoing regulatory guidance and advisory support to the Business cross-functional teams to ensure compliance and execution alignment.
• 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: FDA regulations (21 Parts 807, 820) FDA guidance documents and eSTAR requirements.
• Experience with Canadian regulations, EU MDR (2017/745) including Class IIa, Tech docs Annex II/III.
• 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:

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