Position Type
Contract
Duration
6 to 12 months
Job Description
Job Title: Regulatory Affairs Contractor
pay rate: 100k
Keyword's: #remotejobs; #RegulatoryAffairsContractorjobs;
Start Date: Immediate
REMOTE ROLE
'We provide a competitive pay and benefits package. This position is offering a Pay of 100k€, however, Belcan considers several factors when extending an offer, including but not limited to education, experience, geographic location, and discipline. Benefits offered may include health care, dental, vision, life insurance; 401(k); education assistance; paid time off including PTO, holidays, and any other paid leave required by law.
GENERAL FUNCTION
We are 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
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.
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
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.
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
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
PREFERRED QUALIFICATIONS
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
Belcan is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.'
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