Philips Sr Regulatory Affairs Specialist 

India, Maharashtra 

136493927

Sr. Regulatory Affairs Specialist
Job Description

Job title:Sr. Regulatory Affairs Specialist

You will be part of the Regulatory Affairs team for our Diagnostic X-Ray unit within Precision Diagnosis business segment

Your role:

• Responsible for implementing global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.
• Advises product design teams on regulatory strategy and requirements for specific new products/solutions.
• Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
• Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and Product registrations such as CE Marking and clinical evaluations.
• Develops and facilitates regulatory submissions for new products/solutions, existing products/solutions.
• Creates, reviews and validates marketing and labeling materials while supporting projects and other key regulatory initiatives.

You're the right fit if:

• You have Bachelor's or Master’s degree or equivalent, preferably in Engineering, Life Scientific field and/or Informatics.
• Minimum of 10 years of experience working in Regulatory Affairs within a medical device industry.
• Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), PMA, Technical Files/Design Dossier).
• Extensive knowledge of MDD, MDR, MedDev’s,QMS standards, safety risk management, software development, cybersecurity and labeling standards, other applicable regulations, standards and applications.
• Experienced in strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities).
• Experienced in formulating and implementing global regulatory strategies to ensure compliance with worldwide regulations to improve product market access.
• An excellent communicator and collaborator who can build and maintain cross-functional partnerships in support of business successes.
• Self-directed with a strong work ethic and with an ability to work in a goal-oriented environment.
• An ability to work on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends. Follows processes and operational policies in selecting methods and techniques for solutions.
• Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.

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