PH Quality & Regulatory regional lead - JAPAC

Job Title

PH Quality & Regulatory regional lead - JAPAC

Job Description

Job Title : PH Quality & Regulatory regional lead - JAPAC

Job Responsibilities :

• . Ensures monitoring of global regulatory requirements for products by leading the development of monitoring systems, delegating responsibilities, and ensuring all regulatory updates are promptly and accurately communicated to the team and stakeholders.
• . Manages execution of global regulatory strategy for international markets by creating and implementing comprehensive plans, aligning regulatory activities with business objectives, and ensuring all activities comply with global standards.
• . Oversees compliance with country-specific regulations for product registration and commercialization by managing the submission process, reviewing and approving documentation, and addressing any regulatory issues or concerns.
• . Manages and strengthens relationships with regulatory agencies by maintaining regular communication, attending industry events, and representing the organization in regulatory discussions and negotiations to ensure positive outcomes.
• . Drives tracking, interpreting, and guiding changes in regulations across different countries by leveraging advanced analytical tools, assessing the impact on the organization, and providing strategic recommendations and detailed reports to senior leadership.
• . Spearheads and communicates regulatory strategy and requirements to product design teams for new products / solutions, facilitating the planning of regulatory initiatives for new product introductions and modifications, and ensuring consistent regulatory compliance.
• . Evaluates new international regulatory guidelines and standards, conducting thorough impact assessments on current and future products, and advising on necessary strategic adjustments to maintain compliance.
• . Sponsors strategic projects, facilitates stakeholder management, and reviews and approves the creation or modification of operational infrastructures to support strategic objectives and drive sustainable results.
• . Leads global regulatory audits and inspections, coordinating with internal teams to maintain records of findings and follows up on actions to ensure international regulatory gaps are filled, ensuring minimal disruption to business operations.
• . Manages talent across the team, while driving employee selection, performance management, compensation management, career development, and ensuring effective operational management.

Minimum required Education :

Bachelor's / Master's Degree in a relevant field

Minimum required Experience :

Minimum 14+ years of experience with Bachelor's / Master's in areas such as Regulatory Strategy, International Regulations, Medical Device Regulations, Product Development, Supply Chain, Quality Management or equivalent.

Preferred Certification :

LEAN Six Sigma or equivalent.

RAPS RAC certification.

Preferred Skills :

Regulatory Requirements

Knowledge of Asian regulations - mandatory

Knowledge of Global Regulations

Knowledge of household regulations with reference to electricals appliances, cosmetics & medical devices

Impact Evaluation

Business Acumen

Stakeholder Management

Compliance Management Systems

Strategic Planning

Regulatory Advocacy

People Management

Knowledge Management

Market Intelligence

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.

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 .

Skills Required

Business Acumen, impact evaluation, Knowledge Management, Market Intelligence, Strategic Planning, Regulatory Requirements, Stakeholder Management, compliance management systems , People Management