Regulatory Affairs Specialist

Philips is hiring a Regulatory Affairs Specialist. Level rates it ; you can apply on Philips.

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Level rates this role Little AI ●○○○: aI is not part of the work.
Level classes it as a mid-level role.
Philips has 797 other open roles on Level.
Posted in the last few days.

AI in this role

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.
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.

How we rate this

Regulatory Affairs Specialist at Philips rates 38 out of 100 for how much of the daily work is AI. That makes it Little AI (AI Level 1 of 4). The level is about AI in the job, not seniority.

Classification

Little AI. AI is not part of the work.

●●●● Builds AI80 to 100
●●●○ Works on AI60 to 79
●●○○ Uses AI40 to 59
●○○○ Little AI0 to 39

Levels come from how often the tools, models and workflows of the role are named in the posting itself. Read the description and count the AI tools, models and workflows it names.