Job Description

Job Title Senior Regulatory Affairs SpecialistJob Title : Senior Regulatory Affairs SpecialistThe Sr. 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 departmentxe2x80x99s overall regulatory strategy plan. At Philips MRI the RA Specialist cooperates closely with Product Development , Clinical Science and Marketing and Sales.Your responsibilitiesResponsible 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 updatesReview and approve engineering changes, advertising, promotional items and labeling for regulatory compliance.Communicate application progress to internal stakeholdersMaintain regulatory files and tracking databases as requiredCommunicate with regulatory agencies as neededCreate an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective waysYour teamYou are part of a team of Regulatory Affairs Specialists based in Best (MRI systems), Bangalore (MRI systems software) and Pune (MRI coils). You will report to the Sr. Manager Regulatory Affairs. Itxe2x80x99s a multicultural team and they are all enthusiastic people striving for the best regulatory compliancy.Our offerWe welcome you to a challenging, innovative environment with great opportunities for you to explore.Our benefits are very competitive and designed around your preferences:We offer a market conform salaryA variable bonusExtensive set of tools to drive your career, such as a personal development budget, free training and coachingHealthy work-life balanceWe are looking forBachelors/Master of Science degree in a software, technical, or biomedical disciplineMinimum of 6-8 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 worldwideExcellent working knowledge of medical device regulations, FDA law, MDR, other global laws and regulationsExperience 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 professionalGood communicator and team player who is able to work in a flexible and goal-oriented environmentStructured way of workingProblem solving and time management skillsIn return, we offer youA meaningful career, with new challenges in our dynamic organization, working in an encouraging multinational and multicultural environment. We are happy to provide you with this opportunity to work with new technologies. You will be surrounded by passionate and committed, colleagues who share your ambition to create outstanding customer experiences. Your work will be ambitious and full of opportunities for growth. Variety and challenge will be part of your daily routines.How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart xe2x80x93 which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home xe2x80x93 for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyonexe2x80x99s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnxe2x80x99t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.Why should you join Philips?Working at Philips is more than a job. Itxe2x80x99s a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.Notice for Philips Job SeekersIt has come to our attention that a group of unknown fraudsters are reaching out to people on LinkedIn and other websites, offering fake employment opportunities and charging a fee in the name of Philips. We have noticed that these emails are using fake domain addresses as opposed to Philips domain (Philips.com). Please note that Philips has a merit-based employee selection practice mentioned on our official website ( ). We do not charge / accept any amount or security deposit from job seekers during the selection process or while inviting candidates for an interview. To find out more, please read :

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