Device Compliance Manager II

该职位来源于猎聘 Role Duties And Accountabilities

• Deliver assigned device regulatory compliance activities, ensuring accurate and timely completion of compliance assessments, notifications, and evidence packages.
• Interpret and apply device specific legislation, regulations, and standards, escalating complex or high risk issues where appropriate.
• Translate regulatory requirements into clear guidance for product development and lifecycle teams.
• Advise on product testing, review test reports, technical files and enable regulatory compliance for PRRP devices and electrical accessories.
• Responsible for the execution of device and electrical accessories product and packaging master artwork compliance assessments
• Support regulatory input into product design decisions, risk assessments, and go/no go discussions.
• Collaborate closely with R&D, Legal/CORA, Quality, Procurement, and End Market teams to embed compliance requirements into ways of working.
• Support supplier engagement activities, including contributing to training or information sharing on device compliance and duty of care requirements.
• Maintain high quality documentation, ensuring traceability, version control, and audit readiness.
• Monitor regulatory intelligence relevant to assigned device areas and flag emerging risks or changes.
• Contribute to process, template, and governance improvements within the Scientific Stewardship team.
• Act as a reliable technical contributor within cross functional project teams, building credibility through strong regulatory judgement and delivery discipline. EXPERIENCE, SKILLS, KNOWLEDGE ESSENTIAL

Experience Required

• 3–7 years’ experience in product regulatory compliance, regulatory affairs, or a related scientific/regulatory field.
• Experience working with regulated consumer products, ideally devices or complex hardware based products.
• Experience of one or more of the following regulatory environments: Consumer product safety regulations & standards: Device certification, REACH Like regulations, Labelling regulations, toys, electronics. Knowledge in Global Market access requirements desirable.
• Experience preparing or contributing to compliance assessments and regulatory documentation.
• Works effectively in a highly dynamic and challenging working environment, balancing competing priorities and providing leadership in a key area of the business. Technical / Functional / Leadership Skills Required
• Strong technical expertise to ensure robust analysis of complex product data and the ability to use that information to make sound recommendations and decisions
• Good organisational skills with the ability to manage multiple priorities.
• Strong planning, prioritisation, risk/issue management, and stakeholder coordination.
• Competence with M365, document management, and compliance systems; data literacy for dashboards.
• Clear written and verbal communication skills, including explaining regulatory requirements to non technical stakeholders.
• High attention to detail, adherence to standards, and continuous improvement mindset.
• Collaborative, delivery focused mindset. Leads the design and implementation of improved processes for assessment and device approvals.
• Ensures the confidentiality of all supplier information is maintained to ensure their trust, support and co-operation. Education / Professional Qualifications / Certifications Required
• Educated to Bachelor’s degree or higher, preferably in a scientific or legal field (e.g., Regulatory Affairs, Law, Chemistry, Life Sciences, Engineering, Public Health, Quality Management, or related discipline). BENEFICIAL
• Comfort with digital tools, including data driven reporting, workflow management, and emerging technologies that support regulatory operations
• Training in project management, risk management, or process improvement (e.g., Prince2, Lean Six Sigma) is advantageous.