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Philips

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3.9

based on 1.5k Reviews

1 Philips Regulatory Affairs Specialist Job

Sr. Regulatory Affairs Specialist

Philips India Limited

3.9

based on 1.5k Reviews

10-15 years

Pune

1 vacancy

Sr. Regulatory Affairs Specialist

Philips

posted 16d ago

Job Role Insights

Flexible timing

Key skills for the job

Healthcare Legal Advisory Operations Regulatory Affairs Risk Management Product Marketing

+ 4 more

Job Description

You will be part of the Regulatory Affairs team for our Diagnostic X-Ray unit within Precision Diagnosis business segment and therefore, influence and shape the regulatory capabilities for future success of Philips.

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.

Youre the right fit if:

You have Bachelors 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.