Senior Regulatory - Drachten, Nederland - Philips

Beschrijving

Job Title

Job Description

As a Senior Regulatory & Compliance Manager at Philips, you play a pivotal role in ensuring the compliance of our innovative products with global regulations and safety standards. Join our Business Grooming & Beauty division, located in Drachten and Eindhoven, where you'll contribute to the development and regulatory strategy of medical and non-medical products.

Your Roles & Responsibilities:

• Your contributions will directly impact the successful market entry of our products, ensuring adherence to Philips policies and global regulatory requirements in a competitive landscape.
• Team and Stakeholders: Enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders including R&D, Product Management, Quality, Clinical Affairs and local Regulatory Affairs teams in the Philips market organization, engaging with over 300 colleagues. Work closely with the central Safety, Compliance, and Regulatory (SCR) organization to drive product safety and compliance.
• In this role, you'll have the opportunity to
• Lead regulatory submissions, contribute to regulatory strategic planning.
• Maintaining accurate Regulatory files and applicable records.
• Provide critical input on regulatory risk assessments to support portfolio selection.
• Maintain strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities, etc.) to ensure that requirements are known early during strategy development, which enables fast market access with the current portfolio in connection with future innovations.
• Participate in New Product Development Teams and provide Regulatory input in these teams including but not limited to the preparation of Regulatory Strategic Plan.
• Ownership of regulatory submissions such as but not limited to initial registrations, changes/variations, and renewals by:
  • Approbation via coordination of timely preparation of requests for Free Sale Certificates.
  • Work with applicable test houses, notified body and competent authorities.
  • Coordination and collection of specific registration information with R&D, Manufacturing, QA, and applicable departments, as vital to support registration requirements.
  • Assist in the preparation of the Technical File for CE marking.
  • Assist in the preparation of the 510(k) submission and acquire/support clearance in the ;/span>
• Participate in the review and approval of labelling and promotional materials.
• Actively participate in a hybrid work environment, aligning with our newly-adopted hybrid work concept.

You're the Right Fit If:

• Minimum of 7 years of experience in product development projects, specifically in the field of electronics consumer products in medical devices.
• Proficient in Safety & Compliance domains with a strong quality mindset.
• Experienced in Risk Management (IEC and knowledgeable about safety standards such as IEC 60601 and IEC 60335.
• Academic degree in Biomedical, Material, Mechanical, or Chemical Engineering or equivalent.
• A network-oriented mindset, proactive attitude, and strong initiative are essential for success in this 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 here.
• Discover our rich and exciting history here.
• Learn more about our purpose here.

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 commitment to diversity and inclusion here.

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