Quality and Regulatory Manager Are you interested in working with an innovative medical company? My client based in Munich is currently seeking an experienced regulatory manager who has expertise within the FDA submission process. If you enjoy academic discussions, face to face working environments and a highly collaborative team culture then this will be an amazing opportunity for you! Key Responsibilities Develop and execute regulatory strategies for product approvals in the US. Prepare, review, and manage regulatory submissions, including technical files, design dossiers, and 510(k)s. Deep understanding of PMA process Ensure compliance with ISO 13485, ISO 14971, and other applicable standards. Work closely R&D, Quality, Clinical, and Marketing teams to align regulatory strategies with business objectives. What You Bring Bachelor’s or master’s degree in Life Sciences, Engineering, or a related field. Minimum of 5 years in Regulatory Affairs, preferably in the medical device industry. Indepth understanding of MDR, FDA regulations, ISO 13485, and risk management standards. Strong organizational skills with the ability to manage multiple projects simultaneously. Excellent written and verbal communication skills in English; proficiency in German is a plus. Proactive and solution-oriented mindset with attention to detail. What we offer 38 hour working week and 30 days holiday Competitive salary ranging between €85,000 and €100,000 depending on experience. If this sounds interesting to you and you would like to know more, please reach out to me at Jack@meliolifescience.com