Regulatory Affairs Specialist

The Regulatory Affairs Specialist will be a key talent in International Regulatory filings and procedures, acting as a central regulatory point person to ensure compliance in markets where Philips products are commercialized. This role involves being an impactful and independent team member on multiple projects, assisting in building a center of excellence for RA operations to enhance compliance, efficiency, and global market readiness, and managing projects across multiple geographies to meet deadlines.

Must Have

• 3-5 years of experience in international regulatory affairs
• Skills in Regulatory Affairs, Dossier Preparation, and experience with Class I and Class II devices
• Any Engineering Degree, preferably in Biomedical Engineering

Good to Have

• Good interpersonal skills
• Strong communication skills

Your role:

• Be recognized as a key talent in International Regulatory filings and procedures.
• Be considered a key regulatory point person in Centralization of Regulatory Operations and enable the regulatory compliance in Markets where Philips products are commercialized.
• Be an impactful member of the Regulatory Affairs (RA) team and trusted by management as an independent regulatory team member on multiple projects simultaneously.
• Assist in building center of excellence for RA operation with purpose to centralize regulatory operations to enhance compliance, efficiency, and global market readiness.
• Function on a multi-geography basis, prioritize, conduct team meetings, and meet project deadlines.

You're the right fit if: (4 x bullets max)

1. Experience- 3-5yrs of experience in international regulatory affairs

2. Skills- Regulatory Affairs, Dossier Preparation, experience in Class, I, II.

3. Education- Any Engineering Degree, prefer in Biomedical Engineering

4. Anything else-

Good Interpersonal skill, holding strong communication skills.