Senior R&D Compliance Engineer

How will you make an impact?We are seeking a highly skilled, self-motivated and experienced Senior R&D Compliance Engineer to join our R&D team. The successful candidate will play a key role in ensuring that our medical devices comply with all relevant regulatory standards and requirements. This role requires a deep understanding of regulatory standards, particularly those related to medical devices, along with extensive experience in testing medical devices as per the standards. This role is crucial for ensuring that products are not only effective but also safe for patients and compliant with international regulations.What will you do?Lead compliance efforts for medical devices, ensuring adherence to regulatory standards including IEC 60601-1, 60601-2, 60825-1, 60601-1-6, ANSI Z80.36, IEC 62471, ANSI/AAMI SW96 and other relevant safety standards.Manage US/OUS environmental regulations for product development (ROHS, REACH, Prop 65, WEEE, POP ...etc.)Lead materials and biocompatibility assessments, testing, strategies, and deliverables in compliance with global (ISO, FDA, EU MDR, Japan) regulatory requirements such as ISO 10993. Develop and maintain compliance strategies to ensure timely product approvals and regulatory submissions.Conduct risk assessments, including DFMEA (Design Failure Mode and Effects Analysis), and generate risk management files in compliance with regulatory requirements.Support the cybersecurity testing and risk assessments to comply with the cybersecurity requirements such as ANSI/AAMI SW96, ISO 81001-1 etc.Manage change orders through digital platforms such as Oracle and Veeva, ensuring accurate documentation and timely implementation.Collaborate with cross-functional teams including Quality Assurance and Regulatory Affairs to drive compliance initiatives and product registrations throughout the product lifecycle.Define and maintain critical component list for legacy and new systems through the life cycle of systems.Stay abreast of changes in regulatory requirements and industry best practices, providing guidance and recommendations to ensure ongoing compliance.Ensure biocompatibility assessment documents are in accordance with the latest version of standard in the electronic document management system.Support System engineering related responsibilities such as Compliance requirements, V&V testing, Environmental testing, Shipping testing, Ingress Protection testing for medical devices.How will you get here?Bachelor's degree in electrical engineering or related field; advanced degree preferred. 10+ years of experience in R&D compliance engineering within the medical device industry, with a focus on complex electro-mechanical devices.Strong understanding of regulatory standards and requirements, particularly 60601-1, 60601-2, 60825-1, IEC 62366, 60601-1-6 ANSI Z80.36, IEC 62471 and other relevant compliance and safety standards.Strong understanding of ROHS, REACH, WEEE and Proposition 65 (hazardous substances regulations) as well as ISO 10993-1. Understanding of Cybersecurity for medical devices such as ANSI/AAMI SW96, ISO 81001-1 etc. preferred.Proven experience in solving EMI/EMC issues and managing change orders through digital platforms such as Oracle and Veeva. Experience conducting usability studies and generating risk management files, including DFMEA. Proficiency in preparing and reviewing compliance documents.Ability to work effectively across different functions and with external partners to drive project success.Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.Detail-oriented with strong analytical and problem-solving abilities.

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