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    Regulatory Affairs Manager - Gurgaon, India - Philips

    Philips
    Philips Gurgaon, India

    1 week ago

    philips background
    Full time
    Description

    Job Title

    Regulatory Affairs Manager

    Job Description

    Job Description

    Business Title: Manager - Regulatory affaire

    In this role, you have the opportunity to make life better.


    Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.

    You are responsible for

    ·

    • To formulate and implement the Businesses and / or Markets long-range regulatory strategies and policies.
    • Create regulatory awareness level as determined within the organization.
    • Enforce a simplified yet robust regulatory processes and harmonizes them across the Clusters and Businesses and Markets and Functions, establishing an effective Management Review process, including routine reporting.
    • Introduce and implement the necessary regulatory processes and tools required to ensure first time right in submissions.
    • Manage compliance to relevant regulations and other Regulatory Requirements and as required, guidelines and policies to all products and operations are consistent with those regulations.
    • Lead the Planning, generation, and coordination of regulatory submissions for product/solution licensing.
    • Proactive stakeholder management in BU.
    • Define and implement appropriate regulatory certifications for sites. Ensures that all products to be released comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions and enablers in the Business and / or Market.
    • Establishes operational objectives and work plans, and delegates assignments to subordinates.
    • Formulates and recommends (changes to) policies and establishes procedures that affect immediate organization(s).
    • Being part and execute the regulatory compliance guidance and regulatory streamline operational excellence between Business groups /sites and Markets to ensure time to market on global initiatives especially related to new projects involving Regulatory for key decision makers.
    • Develop and maintain, execute and track elicit regulatory requirements as per each country required for regulatory compliance and local regulations and tracking progress of project trackers for the markets impacted against planning, submissions and approvals deadlines

    You are a part of

    You are part of ISC (India Subcontinent) Regulatory team. Reporting line of this position is to Head RA, ISC. You will have exposure to a multitude of medical devices, Business groups and sites and workflow solutions and services. This position partners with business leaders, marketing, quality, and legal among other functional areas where you will guide the related stakeholders in application of all applicable regulatory requirements, ensuring gap analysis, regulatory assessment and impact for a successful regulatory submission and approval in each impacted country.

    To succeed in this role, you should have the following skills and experience.

    • Strong knowledge of appropriate regional and global medical device regulations, requirements and standards.
    • 10-12 years of experience in medical device industry in India
    • Experience in assembling the technical documentation files or design dossiers
    • Strong project management skills
    • Ability to interpret applicable regulations to ensure compliance in a changing regulatory landscape
    • Ability to work nimbly, innovative approach to problem solving
    • Ability to work in a matrix organization and being agile
    • Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment

    Why should you join Philips?

    Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 2.5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

    To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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