Philips Senior Regulatory Affairs Manager 

Costa Rica 

221280814

Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager

In addition, this position will manage Regulatory staff by outlining regulatory strategy, setting work direction, and measuring performance. Provides regulatory training and strategic regulatory assessments to the research and development teams in support of modern technology development that is cognizant of product testing and other requirements for regulatory approval in the international markets.

You are responsible for

• Acts as Manager for International submissions and to work with multiple project teams and in-country/regional Regulatory Affairs teams. In-country/Regional Regulatory Affairs teams may involve Philips associates and/or external customers.
• Acts as conduit for Q&A that may originate from business unit project team, in-country/regional Regulatory Affairs team, or governing regulatory body (as communicated by in-country team).
• Responsible for communicating business priorities to the Regulatory submissions team.
• Leading routine calls with Marketing and Regulatory leadership to discuss registration status and priorities.
• Participates in discussions with business unit associates, both inside and outside of Regulatory Affairs, on country requirements
• May involve acting as lead for implementation of new country regulations and requirements. This can include process updates and training.

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

• Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
• Advanced English communication skills
• Fully qualified professionals who have advanced beyond entry level.
• Has working knowledge of company products and services.
• Frequently interacts with functional peer groups. Interaction normally requires the ability to gain cooperation of others.
• Prefer to have 5-10 years of experience in the medical device industry
• Familiar with regulatory documents and international registrations, prefer to have worked in a regulated industry
• Experience in supporting international registrations

How we work together

Indicate if this role is an office/field/onsite role.

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.
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