Regulatory Affairs Manager

3 weeks ago

Bengaluru, India Philips Full time
JOB DESCRIPTION

Job Title

Regulatory Affairs Manager

Job Description

Job Title : Regulatory Affairs Manager

Position Summary:

You are part of Philips Patient Care Informatics (PCI) Regulatory Affairs Organization. The Regulatory Affairs team comprises a group of enthusiastic professionals across the globe that work as a cohesive team to ensure regulatory compliance of Philips PCI products which are in the space of Virtual Care, Cardiovascular Care, Acute Care, and EMR. You will take the lead in influencing and shaping the regulatory capabilities for future success of Philips. 


Duties and Responsibilities:

Serve as RA Representative on project teams, develop and implement global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.

Develops and facilitates regulatory submissions for new products/solution and existing products/solutions. Ensure regulatory submissions are accurate and verifiable against source documents to confirm compliance and traceability.

Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. 

Participants in internal and external Quality System Audits.

Reviews and validates marketing and labeling materials while supporting projects and other key regulatory initiatives.

Ensure compliance and act in accordance with Philips General Business Principles (GBP) and Information Security related policies.

Fulfills selected Quality System requirements as described within the Quality Systems (related to regulatory assessments, promotional materials review, change order reviews, CAPA reviews).

Fulfills selected requirements under the European MDR, MDD, Japan PAL and Canada CMDR, etc. as defined within SOPs and other documents.

Education/Skills and Experience Requirements:

Bachelor’s degree in a science, engineering, or health-related discipline.

8-10 years of working experience in FDA and/or EU MDR regulated medical device/health tech environments - Mandatory

Experience with successful preparation and submission of Technical Documentation, 510K, De Novo, PMA, and registrations of medical devices globally is highly preferred.

Practical experience with international regulatory submissions/registrations is desired.

Operational knowledge of FDA QSR, ISO 13485, ISO 14971, IEC 62304, and other applicable regulations and standards related to software medical devices is preferred.

Experience with software development life cycle, artificial intelligence, data science, and/or software testing is highly preferred.

Contribute as a team player who can work in a matrixed environment with teams in different locations.

Ability to travel 5-10%.

In return, we offer you

At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2030, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy, respiratory care and services.

How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:
There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

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