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Principal Regulatory Affairs Specialist

Posted 4 months agoViewed

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💎 Seniority level: Principal, 6 years

📍 Location: USA

💸 Salary: 125000 - 140000 USD per year

🔍 Industry: Clinical-stage endovascular brain computer interface

🏢 Company: Synchron👥 11-50💰 $75,000,000 Series C over 2 years agoComputerMedicalMarketingMedical DeviceInformation TechnologyManufacturing

🗣️ Languages: English

⏳ Experience: 6 years

🪄 Skills: Project ManagementProduct DevelopmentStrategyCommunication SkillsCollaborationNegotiationAttention to detailDocumentationComplianceCross-functional collaboration

Requirements:
  • 6 years of experience in U.S. and global Class II or III medical device regulatory affairs.
  • Submissions experience in medical devices, SaMDs, AI/ML-enabled devices, and digital health software.
  • Experience in developing complex submissions with strong organization and attention to detail.
  • Ability to work independently and across functions with minimal supervision.
  • Knowledge of ISO 13485, design controls, IEC 60601, ISO 14708.
  • Understanding of quality, clinical, and regulatory processes.
  • Strong technical writing, negotiation, and communication skills.
  • Experience in supporting audits.
Responsibilities:
  • Participate in Product Development teams providing regulatory input.
  • Write and compile regulatory submissions such as IDEs, QSubmissions, PMAs.
  • Lead regulatory project management and drive submissions to approval.
  • Create necessary SOPs and materials for regulatory compliance.
  • Advise the team on regulatory requirements for submissions and post-market obligations.
  • Contribute expertise to improve workflows and submission processes.
  • Educate and train the team on regulatory and quality processes.
  • Manage multiple projects in a fast-paced environment.
  • Develop relationships with regulatory advisors.
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  • Bachelor’s degree in life sciences, engineering or other relevant fields, advanced degree preferred.
  • Experience: 15+ years of experience in regulatory affairs management, preferably with AI and SaMD.
  • Expertise: Demonstrated knowledge of FDA regulations, ISO/EN standards and global regulatory requirements for medical devices.
  • Leadership: Proven ability to lead regulatory and quality initiatives, including successful FDA submissions and audits.
  • Technical Skills: Familiarity with QMS software and tools, as well as regulatory submission platforms.
  • Communication: Strong communication and interpersonal skills, with the ability to engage cross-functional teams and external stakeholders.
  • Problem-Solving: Skilled in identifying and addressing regulatory and quality challenges proactively.
  • Experience with new product development standards and documentation for software products.
  • Nuanced experience in regulatory submissions and technical documentation for medical devices, software and services.
  • Ability to communicate and interact with regulatory agencies and consultants.
  • Excellent written and verbal skills.
  • Certifications: RAC (Regulatory Affairs Certification) or similar credentials are a plus
  • Product Certification: Lead efforts for regulatory submissions and approvals, including FDA traditional and special 510(k) submissions, de novo requests, CE marking, and other certifications required for market entry.
  • Submission Management: Develop and implement regulatory strategy to ensure advancement of product pipeline and business continuity.
  • Regulatory Planning: Develop regulatory plans for devices currently commercialized, devices undergoing FDA review per TAP and Breakthrough Device Designation programs.
  • Risk Management: Develop and maintain risk management processes, ensuring compliance with ISO 14971 and related standards.
  • Policy Development: Establish and maintain company policies and procedures to support regulatory and quality initiatives.
  • Cross-Functional Collaboration: Work closely with R&D, product, and clinical teams to integrate regulatory requirements into product development and lifecycle management.
  • Audits and Inspections: Support internal and external audits, including FDA and ISO inspections, and ensure readiness for all regulatory reviews including technical files, dossiers, Medical Device DHFs, etc.
  • Training and Support: Provide training and guidance to internal teams on regulatory and quality requirements.
  • Continuous Improvement: Identify opportunities to enhance regulatory and quality processes, driving efficiency and compliance.
  • Regulatory Intelligence: Stay current with changes in regulations, standards, and industry trends, ensuring the company remains ahead of compliance requirements.
  • Escalates business critical information in relation to regulatory impact. Evaluate risk and regulatory solutions to product and clinical safety issues during clinical phases.
  • Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
  • Draft Pre-Submission and regulatory application documents.Represent the company’s objectives and strategy while communicating with FDA and other regulatory bodies.
  • Perform regulatory assessment of product changes, develop and implement processes to ensure regulatory compliance and risk based change assessments.
  • Review and approve marketing materials to ensure compliance with advertising and promotional regulations.
  • Prepare, or contribute to the preparation of post market surveillance plans and evaluate post-market data.

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