Philips
Freelance Regulatory Affairs Specialist
Your challenge
The Regulatory Affairs Specialist (RA specialist) is responsible for the coordination and preparation of regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc). The RA specialist also provides strategic input during product creation process and contributes to the department´s overall regulatory strategy plan. At Philips MRI the RA Specialist cooperates closely with Product Development , Clinical Science and Marketing and Sales.
Your responsibilities
Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.
Responsible for the planning, coordination and preparation of document packages for regulatory submissions to the US, EU, Canada and Asian countries [e.g. 510(k) Pre-market Notifications, CE Marking, Health Canada, NMPA, JPAL].
Collaborate with worldwide colleagues regarding license renewals and updates
Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.
Communicate application progress to internal stakeholders
Maintain regulatory files and tracking databases as required
Communicate with regulatory agencies as needed
Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways
Your team
You are part of a team of Regulatory Affairs Specialists based in Best (MRI systems), but also supporting Regulatory activities in Pune (MR Coils). You will report to the Sr. Manager Regulatory Affairs. It´s a multicultural team and they are all enthusiastic people striving for the best regulatory compliancy.
We are looking for
Bachelors/Master of Science degree in a software, technical, or biomedical discipline
Minimum of 4-6 years of experience in medical device regulated environment.
Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide
Excellent working knowledge of medical device regulations, FDA law, MDR, other global laws and regulations
Experience in supporting international registrations (FDA) and clinical investigations (preference)
Regulatory Affairs Certification (in the areas of US, EU, CA, and/or global regulatory affairs). (preference)
Knowledge of the NMPA requirements (preference)
Excellent verbal and written communication skills (English)
Enthusiastic, self-motivated regulatory professional
Good communicator and team player who is able to work in a flexible and goal oriented environment
Structured way of working
Problem solving and time management skills