Regulatory Affairs Business Specialist

Regulatory Affairs Business Specialist (Contract)

Location: Best, Netherlands

Duration Assignment: 4 months (with possible extension)

Contract: via a Randstad company

Hours/week: 40

Budget range: 3800,- EUR - 5300,- EUR

In this role, you will have the opportunity to:

Make life better!In this role, you challenge the complexity of regulatory affairs in the health technology sector by collaborating with cross-functional teams to ensure regulatory compliance and product safety. You will work on regulatory strategies and submissions, contributing to continuous improvement processes.

When you choose to work at Philips, you’ll work on life-changing projects; and contribute to innovative health technologies and solutions that improve billions of lives around the world.

You will be responsible for:

• Implementing global regulatory strategies and roadmaps by leveraging market insights and product marketing strategy to align with business goals.

• Working under general supervision, exercising independent judgment while ensuring adherence to company policies and regulatory requirements.

• Demonstrating substantial understanding of the regulator's role in the Quality System and maintaining a strong awareness of product lines and customer needs.

• Resolving moderately complex regulatory requests, leading safety risk assessments, and managing incidents in Trackwise with effective corrective actions.

• Monitoring and addressing potential regulatory impacts on product safety, implementing continuous improvement processes, and managing regulatory risks proactively.

• Supporting establishment registration and listing, and UDI/Global Trade Identification Number (GTIN) activities in collaboration with global and regional Regulatory Affairs teams.

• Coordinating and facilitating witness testing to ensure compliance with safety regulations, maintaining communication with certification bodies and regulatory personnel.

• Managing regulatory planning for new product introductions and product changes, ensuring compliance throughout the product lifecycle.

• Developing regulatory plans and providing guidance on risk assessment and corrective actions for product registrations (e.g., CE Marking, clinical evaluations).

• Preparing and facilitating regulatory submissions for new and existing products/solutions, ensuring accuracy and completeness for expedited approvals.

• Creating and reviewing marketing and labeling materials to ensure compliance with regulatory standards.

• Recommending enhancements in systems and processes to improve effectiveness and compliance, including revisions to Regulatory SOPs and templates.

• Implementing safety and compliance requirements for product development projects, integrating regulatory standards through memos, training sessions, and deployment strategies.

• Overseeing safety certifications and country-specific approvals to meet international regulatory standards.

To succeed in this role, you should have the following skills and experience:

• Bachelor’s or Master’s degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law, or equivalent.

• Minimum 2 years of experience in Regulatory Affairs, Quality Compliance, or Product Development in the Medical Devices Industry (or no prior experience with a Master’s degree).

• RAPS RAC certification preferred.

• Strong understanding of regulatory requirements and conformity assessment.

• Experience in document auditing, data management, and regulatory reporting.

• Knowledge of product registrations and labeling requirements.

• Ability to develop and implement regulatory strategies and risk mitigation plans.

• Proficiency in stakeholder management and project management.

• Experience with continuous improvement processes and regulatory compliance.

• Excellent communication and problem-solving skills.

• Ability to work independently and manage complex projects.

In return, we offer you:

For this project, you’ll work for Philips and become a contract or permanent employee of a Randstad company. As a contractor at Philips, you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise, and become an even more sought-after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.

Are you ready to apply?