Philips Regulatory Specialist in Pune, India

1) Review development quality reports and plans to ensure that the information required for submissions is adequate

2) Plan, generate, and coordinate regulatory submissions for product/solution licensing

3) Coordinate testing required to support regulatory submissions

4) Review and approve product/solution labeling and product/solution-related marketing communications (generally at BIU and Field)

5) Maintain existing regulatory filings/ licenses, managing updates and related change control processes (generally at the BIU and field level)

6) Provides product design teams with information on regulatory strategy and requirements for specific new products/solution.

7) Supports regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.

In this role, you have the opportunity to Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards (not in the field)

You are responsible for

  • Review development quality reports and plans to ensure that the information required for submissions is adequate

  • Plan, generate, and coordinate regulatory submissions for product/solution licensing

  • Coordinate testing required to support regulatory submissions

  • Review and approve product/solution labeling and product/solution-related marketing communications (generally at BIU and Field)

  • Maintain existing regulatory filings/ licenses, managing updates and related change control processes (generally at the BIU and field level)

  • Provides product design teams with information on regulatory strategy and requirements for specific new products/solution.

  • Supports regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.

You are part of progressive & energetic Quality & Regulatory team that contributes directly to the growth of the business. With global headquarter of Mobile Surgery, Philips HIC, Pune is playing a key role in Philips global strategy for Image-Guided Therapy. With Philips HIC, the foundation was laid to touch billions of lives and reiterate Philips commitment towards Indian and growth healthcare markets

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

  • Bachelor Degree in Mechanical/Electronics

  • Provides product design teams with information on regulatory strategy and requirements for specific new products/solution.

  • Supports regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.

  • Familiarity with preparation and submission of 510(k), PMA, or international documents or

  • registration and marketing of medical device worldwide preferred.

  • Working knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations.

  • Some experience in supporting international registrations and clinical investigations

  • Team player

  • Leadership skills and drive for results

  • Mindset to simplify and reach to solutions with speed.

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 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .

Contact

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