Regulatory Affairs Expert (Medical Devices) till Sunmedic AB

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Additional Information

1) About the job Sunmedic is a forward-thinking medical device company dedicated to delivering innovative, safe, and effective products for patients. We are seeking a motivated Regulatory Affairs Expert to join our team and help ensure our products meet all regulatory requirements across markets. This role offers the opportunity to influence global regulatory strategies, collaborate with cross-functional teams, and contribute to bringing life-saving devices to patients. 2) What you will do - Develop and implement regulatory strategies for medical device products across markets, with a focus on MDR compliance. - Prepare, assemble, and submit regulatory documentation (technical files, PMCF/PSUR where applicable, EU MDR/UK MDR, 510(k) for the US, etc.) and manage lifecycle activities. - Monitor regulatory changes and provide guidance to product development teams to ensure ongoing compliance. - Liaise with competent authorities, notified bodies, and other external stakeholders; prepare for and support regulatory inspections and audits. - Maintain and update technical documentation, quality systems records, labeling, and essential performance documentation. - Lead regulatory risk assessments and material changes (design changes, new indications, claims, or intended uses) to determine regulatory impact. - Support post-market surveillance activities and compliance initiatives. - Provide regulatory training and mentorship to internal teams as needed. - Collaborate with Quality Assurance, Clinical, Pharmacovigilance, and Regulatory Operations to ensure coherent regulatory submissions and post-market commitments. 3) Who you are - You are a proactive, detail-oriented regulatory professional with a collaborative mindset. - You thrive in a fast-paced, cross-functional environment and can translate complex regulatory requirements into actionable plans. - You communicate clearly with internal teams and external stakeholders. - You are accountable, ethical, and committed to patient safety and product quality. 4) What you have - Education: Bachelor's or Master's degree in Regulatory Affairs, Life Sciences, Engineering, Pharmaceuticals, or a related field. - Experience: At least 2 years of hands-on regulatory affairs experience in the medical device industry. - Language: Proficiency in English (written and spoken). - Skills: - Knowledge of quality management systems (ISO 13485) and regulatory inspections. - Strong experience navigating regulatory frameworks, with emphasis on MDR (EU MDR) topics. - Ability to work with complex regulatory requirements and translate them into practical development plans. - Experience preparing regulatory submissions and managing lifecycle activities. - Familiarity with other markets (e.g., US 510(k), UK MDR) is a plus. - Excellent organizational and documentation skills; attention to detail; ability to manage multiple priorities. - Strong communication and teamwork capabilities. Nice-to-have (optional) - Experience with post-market surveillance, clinical evaluation reports, and safety reporting. - Project management experience or certification.

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