BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs and/or related experience * Strong experience in regulatory affairs and quality management, preferably in medical devices, ideally with experience in standalone or embedded medical device software and IEC 62304, or in pharma * Certifications in ISO 134485, MDSAP, PRRC, any other certification related to Life Science/Regulatory affairs is a plus * Develop and implement global regulatory pathways for product authorizations * Oversee preparation and submission of regulatory documents to authorities * Ensure compliance of all products throughout their lifecycle, from authorization to discontinuation and ensure regulatory compliance for product labeling and support clinical trials * Integrate regulatory elements into business processes to minimize approval delays and rejections
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