Technical lead - MDR, ISO 13485, MDD

Technical Lead - MDR, ISO 13485, MDDThe Technical Lead for MDR, ISO 13485, and MDD is responsible for leading technical activities related to medical device regulations compliance, including ISO 13485 and Medical Device Directive (MDD) requirements. The role involves overseeing the development and maintenance of processes and systems to ensure adherence to regulatory standards in the healthcare industry.Key ResponsibilitiesLead technical initiatives to achieve compliance with medical device regulations, specifically ISO 13485 and MDD.Develop and implement strategies to ensure that products meet the necessary quality and safety standards.Collaborate with cross functional teams to integrate compliance requirements into product development processes.Conduct audits and assessments to identify gaps in compliance and implement corrective actions.Stay updated on changes in regulations and standards related to medical devices and ensure timely implementation within the organization.Skill RequirementsIn-depth knowledge and experience with medical device regulation (MDR), ISO 13485, and Medical Device Directive (MDD).Strong understanding of quality management systems in the context of medical devices.Proficiency in interpreting and applying regulatory requirements to product development processes.Excellent communication skills to effectively engage with internal teams and external stakeholders.Attention to detail and strong analytical skills to assess compliance gaps and propose solutions.Other RequirementsRelevant certifications in medical device regulations (e.g., Certified ISO 13485 Lead Auditor) would be advantageous.Compensation and BenefitsA candidate's pay within the range will depend on their skills, experience, education, and other factors permitted by law. This role may also be eligible for performance-based bonuses subject to company policies. In addition, this role is eligible for the following benefits subject to company policies: medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance; employee assistance program; 401(k) retirement plan; 10 days of paid time off per year (some positions are eligible for need-based leave with no designated number of leave days per year); and 10 paid holidays per year.