Regulatory Affairs Specialist

Job Title

Job Description

Minimum required Education:
Bachelor's Degree in any Engineering, Biomedical Engineering.

Minimum required Experience:
Bachelor's Degree with 6+ years of experience in Regulatory Affairs, Quality Compliance, Product Development in Medical Devices Industry or equivalent.

Minimum required Certification:
N/A

Job title:
Regulatory Affairs Specialist

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- 6+yrs 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.
 

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.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite 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.
• Discover our rich and exciting history.
• 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 here.