Description

In this role, you will navigate the complexities of regulatory affairs, ensuring product compliance from authorization to discontinuation while leading efforts to secure necessary approvals across various markets.

Requirements

• •BS/MSc in Life Sciences, Engineering, Optics, Regulatory Affairs, 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
• •Understanding and proven track record working with notified bodies and regulatory authorities in Europe
• •Strong knowledge of regulatory requirements and processes in relevant markets combined with advanced project management skills, time and budget management proficiency in a multicultural environment
• •Certifications in ISO 13485, MDSAP, PRRC, or any other certification related to Life Science/Regulatory affairs is a plus
• •Experience with FDA requirements and successful submissions (e.g., 510(k) and FDA audits) in addition to knowledge regarding digital processes in RA (incl. submissions, digitalization and intelligence)
• •Strong analytical and problem-solving skills as well as a solid customer and result oriented focus
• •Excellent communication and negotiation skills expressed with fluency in English and German

Tasks

• •Develop global regulatory pathways for product authorizations
• •Prepare and submit regulatory documents to authorities
• •Ensure product compliance throughout their lifecycle
• •Maintain regulatory compliance for product labeling
• •Support clinical trials with regulatory guidance
• •Lead efforts to obtain approvals and licenses in various markets
• •Integrate regulatory elements into business processes
• •Maintain and update regulatory documentation for Quality Management Systems
• •Assess marketing claims for regulatory compliance

Tools & Technologies