Regulatory Affairs Manager

Job Title

Regulatory Affairs Manager

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.

Regulatory Affairs Manager

In this role, you will be reporting directly to the Head of Patient Safety and Quality APAC.

You are responsible for:

• APAC portfolio
• To formulate and implement the Businesses and / or Markets long-range regulatory strategies for APAC (Asia Pacific).
• Main point of contact between Business Unit, Market and Local Business Team for product registration preparation and renewals.
• Create regulatory awareness level as determined within the organization.
• Supports implementation of simplified yet robust regulatory processes for registrations and labeling deviations across the HPM Businesses.
• Introduce and implement the necessary regulatory processes and tools required to ensure first time right in submissions.
• Ensure compliance to relevant regulations and other Regulatory Requirements and as required, guidelines and policies to all HPM products and operations are consistent with those regulations.
• Lead the Planning, generation, and coordination of regulatory submissions for HPM product/solution licensing.
• Proactive stakeholder management.
• 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.
• Formulates and recommends (changes to) policies and establishes procedures that affect immediate organization(s).
• Define 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.
• Establish, maintain and implement policies and practices related to creating and maintaining an active involvement in the legal and regulatory processes of covered Competent Authorities.

To succeed in this role, you’ll need a customer-first attitude and the following:

• Bachelor’s Degree in related disciplines.
• Minimum 5 years working experience in relevant fields.
• Understanding of Asia Pacific Regulations.
• Experience compiling an ASEAN Dossier. 
• Ability to present and negotiate effectively in multiple areas of the customers’ environment.
• Excellent in interpersonal and communication skills with proven ability to influence all levels of stakeholders.
• Excellent organizational and time management skills.

How we work together:

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.

About Philips:

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.