Regulatory Affairs Lead, Health Systems APAC

at  Philips

Job Title
Regulatory Affairs Lead, Health Systems APAC
Job Description
Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.
But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common.
An unwavering sense of purpose
and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.
The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.
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

• Formulating and implementing the Businesses and APAC Zone long-range regulatory strategies and policies.
• Create regulatory awareness level as determined within the organization.
• Enforce 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 local regulatory requirements across APAC, in addition FDA, EU-MDR 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 Region/ Zone.
• 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)
• Facilitate the coordination of the activities of a section or department with responsibility for results, including costs, methods and staffing.
• Manages activities of two or more sections or departments.
• Manages local authority engagements.
• Active engagement with the industry forum.

You are a part of
You are part of Growth Region Regulatory team responsible for APAC Zone. Reporting line of this position is to Head RA- Growth Region. 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 APAC
• Strong relationship and engagement with local authorities across APAC Zone.
• Experience in assembling the technical documentation files or design dossiers
• Strong project management skills
• Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
• 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.
• Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
• Exercises supervision in terms of costs, methods, and staffing.

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.
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:

• We believe in the importance of impactful collaboration: There’s a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
• We embrace flexibility: 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.
• We want to be at our best: 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.
Visit our careers website to explore what it’s like
working at Philips
, read stories from our
employee blog
, find information about our
recruitment process
and answers to some
frequently asked questions
.
By submitting your resume and related information in the manner set out in this job post, you consent for Philips and Philips’ authorized nominee to collect, process, transfer and store your personal data for purpose of the application for the above-mentioned job opportunity. Further, in the event you provide any personal information of another data subject as referee, you confirm that the relevant data subject consented to the disclosure of such personal data to Philips and Philips’ authorized nominee. For more information and details on our Privacy Policy, please visit
this link.

You are responsible for

• Formulating and implementing the Businesses and APAC Zone long-range regulatory strategies and policies.
• Create regulatory awareness level as determined within the organization.
• Enforce 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 local regulatory requirements across APAC, in addition FDA, EU-MDR 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 Region/ Zone.
• 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)
• Facilitate the coordination of the activities of a section or department with responsibility for results, including costs, methods and staffing.
• Manages activities of two or more sections or departments.
• Manages local authority engagements.
• Active engagement with the industry forum

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 APAC
• Strong relationship and engagement with local authorities across APAC Zone.
• Experience in assembling the technical documentation files or design dossiers
• Strong project management skills
• Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways
• 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.
• Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
• Exercises supervision in terms of costs, methods, and staffing