Senior Regulatory Affairs Specialist (m/w/d) Medical Device

at  Philips

IN THIS ROLE, YOU HAVE THE OPPORTUNITY TO MAKE LIFE BETTER

Looking at the challenges the world is facing today Philips purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

YOU ARE RESPONSIBLE FOR

• Develop global regulatory strategies to meet business objectives and collaborate across a matrixed organization to ensure global success of products
• Participate in cross-functional project teams and provide regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory/legislative initiatives and product marketing strategy for new product introduction
• Responsible for worldwide product registration submissions/approvals as well as license renewals and updates.
• Prepare FDA and Health Canada submissions and European Technical Documentation (EU MDR) for product changes and/or new product introductions.
• Maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed
• Review and approve product labeling and promotional materials to assure compliance with applicable regulatory requirements.
• Analyze and optimize RA processes together with cross functional partners such as Quality Management, Regulatory Affairs, Clinical Affairs in order to improve procedures or integrate new and changing Standards and regulations

TO SUCCEED IN THIS ROLE, YOU SHOULD HAVE THE FOLLOWING SKILLS AND EXPERIENCE

• Degree in mechanical engineering, electrical engineering or applied sciences or related discipline
• Prior proven experience of the 510(k) or Q-Sub or De Novo or PMA Submission and approval Process
• Several years of experience plus professional experience in medical device regulatory affairs
• Strong experience creating other global regulatory submission plans, submission file preparation and receiving submission approval (EU, Canada, etc)
• Expertise with interpreting and implementing various medical device standards and global medical devices,
• such as electrical safety, EMC testing (e.g., IEC 62304, IEC60601 series etc.)
• Experience with systems for quality management, product development and follow-up of procedures is an advantage.
• Experience in process improvement, process implementation, facilitation of critical meetings.
• Experience in project management is required.
• Knowledge and application of medical device QMS is required (e.g., ISO 13485, MDSAP etc.)
• Coaching/mentoring skills to develop talents is required.
• Fluent in English, other European languages beneficial