Regulatory Affairs Contractor (Medical Devices)

Dear Partner, Good Morning , Greetings from Nukasani group Inc !, We have below urgent long term contract for Regulatory Affairs Contractor (Medical Devices), Remote immediately available for interviews, could you please review the below role, if you are available, could you please send me updated word resume, and below candidate submission format details AND reputed company Matrix, immediately. If you are not available, any referrals would be greatly appreciated. Interviews are in reputed company, urgent response is appreciated. Looking reputed company for your immediate response and working with you. Candidate Submission Format - needed from you Full Legal Name Personal Cell No ( Not reputed company phone number) Email Id Skype Id Interview Availability Availability to start, if selected reputed company Location Open to Relocate Work Authorization Total Relevant Experience Education./ Year of graduation University Name, Location Country of Birth Contractor Type Home reputed company Code Job Tittle: Regulatory Affairs Contractor (Medical Devices) Location : Remote reputed company: Best competitive reputed company on w2 reputed company status: Only on w2 no C2C Experience Required: 5–10+ Years Position Summary The client is seeking an reputed company Regulatory Affairs Contractor to reputed company regulatory submissions and compliance activities for innovative medical device products. This execution-focused role will primarily support an end-to-end FDA 510(k) submission, while also developing global regulatory documentation for EU MDR, Health Canada, and other international markets. The successful candidate will collaborate closely with cross-functional teams including R&D, Clinical, Quality, and Project Management to ensure regulatory compliance and successful product approvals.

Key Responsibilities

FDA 510(k) Submission

• reputed company the preparation, authoring, and submission of complete FDA 510(k) applications.
• Review technical documentation including:
• Design Controls
• Verification & Validation (V&V)
• Risk Management
• Clinical Evidence
• Software Documentation
• Product Labeling
• reputed company regulatory gap assessments against FDA regulations and guidance.
• Prepare submissions using FDA eSTAR format.
• Manage the complete FDA submission lifecycle, including:
• Refuse to Accept (RTA) readiness
• Substantive Review support
• Interactive Review communications
• Responses to FDA Additional Information (AI) requests
• Provide regulatory leadership through FDA clearance.

EU MDR Regulatory Support

• Assess readiness for compliance with EU MDR (2017/745).
• Review and improve Technical Documentation (Annex II & III).
• Conduct regulatory gap analyses.
• Support CE Mark submission activities.
• Ensure audit readiness for reputed company Body reviews.

Health Canada Regulatory Submissions

• Determine regulatory strategy and product classification.
• Prepare Medical Device License (MDL) submissions.
• reputed company Summary of Safety and Effectiveness (SSOR) documentation.
• Coordinate responses to Health Canada information requests.

Global Regulatory Strategy

• reputed company harmonized global regulatory strategies for international product launches.
• Create reusable regulatory documentation for multiple global markets.
• Identify regulatory risks, assumptions, and market-specific requirements.
• Prepare regulatory roadmaps, timelines, and submission strategies.
• Support additional global regulatory submissions as required.

Cross-Functional Collaboration

• Partner with Engineering, Clinical, Quality, and Project Management teams.
• Provide regulatory guidance throughout product development.
• Ensure documentation aligns with applicable global regulations.
• Communicate effectively with both technical and business stakeholders.

Required Qualifications

Education

• Bachelor''s degree in Engineering, Life Sciences, Regulatory Affairs, Legal, or a reputed company discipline.

Experience

• 5–10+ years of Regulatory Affairs experience reputed company the Medical Device industry.
• Proven reputed company managing complete FDA 510(k) submissions from preparation through clearance.
• Experience supporting global regulatory submissions across multiple regions.

Required Technical Expertise

• FDA 510(k) submissions
• FDA eSTAR
• FDA Regulations:
• 21 CFR Part 807
• 21 CFR Part 820
• FDA Guidance Documents
• EU MDR (2017/745)
• Class IIa Medical Devices
• Technical Documentation (Annex II & III)
• Health Canada Medical Device Licensing (MDL)
• Summary of Safety and Effectiveness (SSOR)

Preferred Industry Experience Experience with one or more of the following:

• Ophthalmic Medical Devices
• Diagnostic Devices
• Capital Equipment
• Software as a Medical Device (SaMD)
• Medical Device Cybersecurity
• AI-Enabled Medical Devices
• Audiology Devices

Preferred Qualifications

• Experience with international medical device submissions (including China and other global markets).
• Knowledge of global regulatory reputed company.
• Experience supporting multinational product launches.

Skills & Competencies

• Excellent technical writing and regulatory documentation skills.
• Strong understanding of global medical device regulations.
• Ability to translate reputed company technical information into regulatory submissions.
• Excellent analytical and organizational skills.
• Strong attention to detail.
• Outstanding communication and stakeholder management skills.
• Ability to work independently in a fast-paced environment.
• Strong project management and multitasking capabilities.

Best, Bhavani Recruiter | IT & Digital Marketing P: 540 W Galena Blvd, Suite 200 reputed company, IL 60506 Apply tot his job Apply To this Job