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Regulatory Affairs Manager

PhilipsPune, Maharashtra, IndiaPosted 16 May 2026

This Regulatory Affairs Manager role at Philips focuses on ensuring global compliance for medical technology products to support patient safety and product approvals. The candidate will collaborate cross-functionally with R&D, Quality, and Product teams to manage the product lifecycle and regulatory submissions. Requirements include extensive experience in medical devices, expertise in FDA/EU MDR standards, and strong project management skills. The role offers exposure to global regulatory frameworks and international collaboration.

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Experience

10-15 years

Function

Operations

Work mode

Hybrid, India

Company

Tier 1

What you will work on

This Regulatory Affairs Manager role at Philips focuses on ensuring global compliance for medical technology products to support patient safety and product approvals. The candidate will collaborate cross-functionally with R&D, Quality, and Product teams to manage the product lifecycle and regulatory submissions. Requirements include extensive experience in medical devices, expertise in FDA/EU MDR standards, and strong project management skills. The role offers exposure to global regulatory frameworks and international collaboration.

TAL's take

Quality 80/1005/5 clarityTier 1 company

Philips is a Tier 1 global healthtech brand offering a well-scoped and senior management role.

The JD provides clear role expectations, specific regulatory standards required, and cross-functional team context.

Salaries at Philips

25.2 LPA average

Based on 63 Grapevine salary entries for Philips.

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Must haves

  • 10-15 years experience in the medical device industry
  • Proven track record of successful submissions
  • Expertise in USFDA 510k, CE certification, and EU MDR
  • Knowledge of ISO 13485, ISO 14971, and 21 CFR 820
  • Capacity to manage multiple high-stakes projects under strict deadlines

Tools and skills

usfda 510k submissionce certificationeu mdriso 13485iso 1497121 cfr 820health canada submissioncdsco submissionmedical device rules 2017capa

Nice to have: regulatory affairs certification (rac).

About the company

Philips is a major global health technology multinational corporation.

Posts mentioning Philips

Requesting a Referral @ Microsoft

I am interested to apply for a Data Scientist position at Microsoft... Anyone who can help me out with a referral, is welcomed to. Position: https://apply.careers.microsoft.com/careers/job/1970393556625277?utm_source=linkedin&domain=microsoft.com&src=LinkedIn TL:DR about me: 1.5+ YoE in Data Science, with experience from Google and Philips.

Bangalore20

How Wankhede treated Indian Cricket team!

Border Gavaskar Trophy is underway. Ash anna recently retired and I can't consider myself lucky enough to see the 4 seniors play for the last time together. Getting to watch them at the iconic Wankhede stadium was nothing short of a dream. It was the third Test, Day 3, of the India vs. New Zealand series. The visitors were bowled out early, leaving India a modest target of 140+ runs. On paper, it seemed like a cakewalk. But, with an out-of-form top order and the ghost of Ajaz Patel's spin heroics, nothing was guaranteed. Ignoring all advices of skipping the match, I finally got my hands on tickets (in black of course). My faith in Wankhede's electric crowd promised this would be worth every penny. By the time I had reached the entry gates, there were atleast a thousand crazy fans waiting to enter on a Sunday morning. Young kids and teens talking in Bambaiya slangs in blue and white jerseys queuing up to see a team that is already down 2 matches and no guarantee of a win. As the chants of “India! India!” got louder, it was clear I wasn’t alone in the madness. While I was still in the queue, suddenly, the crowd inside went quiet. A wicket had fallen. Moments later, the roar of the crowd returned as Virat Kohli walked out to bat. The excitement was short-lived though, as Kohli was run out soon after. India was 3 wickets down in no time. I feared the crowd might turn against the team looking at their passion. But, I was horribly wrong in questioning the unwavering passion of Mumbaikar’s for cricket. As wickets fell, tension was palpable. But this crowd was something else. No jeers, no anger, just unwavering faith. As Pant began his innings, crowd rallied behind him with chants of his name. Every run was applauded. As Pant completed half century, crowd went berserk, as if we had won the game. It didn’t matter that India was still on the back foot. It was a moment to cherish. As game progressed, chants of Ganpati Bappa Morya accompanied with Dhols kept getting louder. Now every dot ball was getting appreciated(Quite a downall)! Despite the setbacks, crowd kept the energy high with Mexican waves and synchronised rendition of Vande Mataram. Pure Goosebumps!! Between all the fervor, Wankhede showed true sportsmanship by appreciating every effort of opponents. Be it a failed catch attempt, or a good fielding effort, all got applause. I vividly remember how crowd appreciated Glen Philips standing on the boundary line for his bowling. After the game finished, crowd didn't waste a minute to wait, expressing their disappointment. The only 2 NZ fans in the stands teased us, 'We can't hear you anymore'. Mumbai fans instead gave back ,'You will hear us at the Lords'. That camaradiere and support was so refreshing to see. Rare to see these days. Wankhede that day wasn’t just a stadium; it was a living, breathing celebration of cricket. The fans showed the world how to love the game, support their team, and respect their opponents—all with civility and unmatched passion. No matter which team won, test cricket definitely did!

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