Regulatory Affairs Specialist

0001 Jakarta; Jakarta Pusat; On-site; IDR 150,000,000 - 300,000,000; Full time

Job summary

Philips Indonesia seeks a Regulatory Affairs Specialist to ensure compliance with global and local regulatory requirements across our healthcare product lines. You will monitor regulatory developments, support global strategies, and manage country-specific registrations and submissions to enable market access.

Responsibilities include providing regulatory guidance throughout development, maintaining documentation, and driving lean improvements while communicating updates and risks to

Qualifications

• Bachelor's degree in related majors.
• Minimum 3 years of experience in Regulatory Affairs related role within healthcare industry.
• Proactive, good communication skills, able to handle complex situations and high responsibilities with a compliance mindset.
• Proficient in English and Bahasa Indonesia (oral and written).

Responsibilities

• Monitor global regulatory requirements, standards, and emerging trends to anticipate changes and assess business impact.
• Develop and support global regulatory strategies aligned with product and business objectives.
• Manage country-specific product registrations and regulatory submissions, ensuring accurate documentation and timely approvals.
• Prepare regulatory submissions for new products, product changes, and lifecycle activities to support market access.
• Provide regulatory guidance throughout product development and conduct compliance and risk assessments, including mitigation strategies.
• Build effective relationships with regulatory authorities, industry bodies, internal stakeholders, and external partners.
• Maintain regulatory documentation, databases, metrics, and records to ensure compliance, audit readiness, and performance monitoring.
• Drive regulatory process improvements using lean methodologies and effectively communicate regulatory updates, risks, and recommendations to stakeholders.

Skills

Fluent English

Bahasa Indonesia

Regulatory Requirements

Global Regulations Monitoring

Data Management

Research & Analysis

Regulatory Agency Liaison

Strategy Implementation

Document Auditing

Product Registrations

Product Labeling

Continuous Improvement

Regulatory Compliance Monitoring

Data Analysis & Interpretation

Operational Excellence Tools

Education

Bachelor's degree in related field

Job description

Job Title Regulatory Affairs Specialist Job Description

Job summary: The role is responsible for ensuring compliance with global and country-specific regulatory requirements, monitoring industry updates and collaborating across functions.

Your role:

• Monitor global regulatory requirements, standards, and emerging trends to anticipate changes and assess business impact.
• Develop and support global regulatory strategies aligned with product and business objectives.
• Manage country-specific product registrations and regulatory submissions, ensuring accurate documentation and timely approvals.
• Prepare regulatory submissions for new products, product changes, and lifecycle activities to support market access.
• Provide regulatory guidance throughout product development and conduct compliance and risk assessments, including mitigation strategies.
• Build effective relationships with regulatory authorities, industry bodies, internal stakeholders, and external partners.
• Maintain regulatory documentation, databases, metrics, and records to ensure compliance, audit readiness, and performance monitoring.
• Drive regulatory process improvements using lean methodologies and effectively communicate regulatory updates, risks, and recommendations to stakeholders.

You’re the right fit if:

• Bachelor's degree in related majors.
• Minimum 3 years of experience in Regulatory Affairs related role within healthcare industry.
• Proactive, good at communication skills, being able to deal with complex situations, high responsibilities and good at compliance mindset.
• Proficient in English language and Bahasa Indonesia both oral and written.

Preferred Certification:

• RAPS RAC certification
• Certified associate in project management (CAPM)
• Six Sigma
• Certified Change Management Professional (CCMP)
• Transformation-related certification or equivalent

Preferred Skills:

• Regulatory Requirements
• Global Regulations Monitoring
• Data Management
• Research & Analysis
• Regulatory Agency Liaison
• Strategy Implementation
• Document Auditing
• Product Registrations
• Product Labeling
• Continuous Improvement
• Regulatory Compliance Monitoring
• Data Analysis & Interpretation & Operational Excellence Tools

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.

About Philips

Are you ready to do the work of your life to help the lives of others? Learn more about our business, discover our rich and exciting history and learn more about our purpose. Learn more about our culture of impact with care.At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights