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Philips Regulatory Affairs Manager India, Karnataka 833560686
Duties and Responsibilities:
Serve as RA Representative on project teams, develop and implement global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.
Develops and facilitates regulatory submissions for new products/solution and existing products/solutions. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Participants in internal and external Quality System Audits.
Reviews and validates marketing and labeling materials while supporting projects and other key regulatory initiatives.
Ensure compliance and act in accordance with Philips General Business Principles (GBP) and Information Security related policies.
Fulfills selected Quality System requirements as described within the Quality Systems (related to regulatory assessments, promotional materials review, change order reviews, CAPA reviews).
Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents.
Education/Skills and Experience Requirements:
Bachelor’s degree in a science, engineering, or health-related discipline.
8-10 years of working experience in FDA and/or EU MDR regulated medical device/health tech environments - Mandatory
Experience with successful preparation and submission of Technical Documentation, 510K, De Novo, PMA, and registrations of medical devices globally is highly preferred.
Practical experience with international regulatory submissions/registrations is desired.
Operational knowledge of FDA QSR, ISO 13485, ISO 14971, IEC 62304, and other applicable regulations and standards related to software medical devices is preferred.
Experience with software development life cycle, artificial intelligence, data science, and/or software testing is highly preferred.
Contribute as a team player who can work in a matrixed environment with teams in different locations.
Ability to travel 5-10%.
Our hybrid working model is defined in 3 ways:
There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
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