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Regulatory Affairs Contractor
Global Channel Management, Inc.Regulatory Affairs contractor specializing in FDA submissions and regulatory compliance in the medical device industry. Conducting assessments and leading submission processes for medical device clearance.
Tech Stack
Tools & technologiesCyber Security
About the role
Key responsibilities & impact- 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 against 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 targeted recommendations to ensure audit-readiness and Notified Body acceptance
- Lead or support submission to obtain CE Mark.
Requirements
What you’ll need- 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 lla, Tech docs Annex ll/lll
- Demonstrated ability to work independently as a contractor in a fast-paced environment
- Experience filing medical device submissions in China and other countries
- Experience with audiology devices
- Experience with artificial-intelligence enabled devices
- 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.
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Global Channel Management, Inc. Website LinkedIn All Job Openings 11 - 50 employees 🎯 Recruiter 🤝 B2B ☁️ SaaS Recruitment
- B2B
- SaaS Global Channel Management, Inc. is a technology company that specializes in recruiting and staff augmentation services. With over a decade of experience, their account managers and recruiters help organizations address challenges in acquiring skilled talent, manage fluctuating skill needs, and reduce training and labor costs. They focus on providing companies with the best talent to meet various staffing needs and timelines across different verticals. Regulatory Affairs Contractor Job not on LinkedIn 🔥 50 minutes ago 🇺🇸 United States – Remote 💵 $99 - $100 / hour ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
- 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 against 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 targeted recommendations to ensure audit-readiness and Notified Body acceptance
- Lead or support submission to obtain 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 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 lla, Tech docs Annex ll/lll
- Demonstrated ability to work independently as a contractor in a fast-paced environment
- Experience filing medical device submissions in China and other countries
- Experience with audiology devices
- Experience with artificial-intelligence enabled devices
- 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. Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Regulatory CMC Manager – Contract 🕒 2 days ago Vertex Pharmaceuticals 1001 - 5000 🧬 Biotechnology 💊 Pharmaceuticals ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Regulatory CMC Manager supporting cell and gene therapy regulatory strategies for Vertex Pharmaceuticals. Involved in regulatory submissions and providing guidance to cross-functional teams. 🇺🇸 United States – Remote 💵 $70 - $80 / hour ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Workplace Safety & Compliance Professional 🕒 3 days ago The Desire Company 11 - 50 📱 Media 🛍️ eCommerce 🤝 B2B Website LinkedIn All Job Openings Workplace Safety and Compliance Professionals creating impactful videos for leading brands. Leveraging expertise to help shoppers make confident purchase decisions. 🇺🇸 United States – Remote 💵 $1.5k / year 💰 $3.3M Venture Round - The Desire Company on 2025-05 ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Consulting Contractor – State Paid Family Leave and Disability Plan Invoicing, Compliance Support 🕒 3 days ago Self Bill Pro 11 - 50 ☁️ SaaS 👥 HR Tech 🤝 B2B Website LinkedIn All Job Openings Consulting Contractor at SelfBill Pro specializing in invoicing and compliance for state paid family leave and disability plans. Provide expert advice on compliant billing processes across multiple states. 🇺🇸 United States – Remote 🔥 Funding within the last year 💰 $2.6M Seed Round - Self Bill Pro on 2025-10 ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Regulatory Operations Documentation Specialist 🕒 June 19 Shionogi Inc. (U.S.) 501 - 1000 🧬 Biotechnology 💊 Pharmaceuticals ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Support Regulatory Operations with electronic submission documentation. Focus on document formatting, quality control, and communication archiving with Health Authorities. 🇺🇸 United States – Remote 💵 $40 - $57 / hour ⏳ Contract/Temporary 🟡 Mid-level 🟠 Senior 🚔 Compliance Senior Compliance Associate – 12 Month Contract 🕒 June 18 OFX 201 - 500 💸 Finance 💳 Fintech 🤝 B2B Website LinkedIn All Job Openings Senior Compliance Associate ensuring compliance with North American regulations at OFX. Collaborating with various departments to manage compliance advisory functions and regulations. 🇺🇸 United States – Remote 💵 $110k - $120k / year ⏳ Contract/Temporary 🟠 Senior 🚔 Compliance View More Compliance Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs
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Hard Skills & Tools
FDA 510(k) submissionregulatory gap assessmentstechnical documentation reviewEU MDR compliancetechnical writingcybersecurity in medical devicesmedical device submissionsaudit-readinessCE Mark submissiondesign controls
Soft Skills
detail-orientedstrong organization skillseffective communicationability to work independentlyability to manage multiple deliverablesleadershipcross-functional collaborationanalytical skillsproblem-solvingadaptability
Certifications
Bachelor's degree in engineeringBachelor's degree in life sciencesBachelor's degree in regulatory affairsBachelor's degree in legal studies