Alajuela, Costa Rica
3 days ago
Regulatory Affairs Specialist
Job TitleRegulatory Affairs Specialist

Job Description

Regulatory Affairs Specialist

In this role, you have the opportunity to:

Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.

You are responsible for

Serve as the liaison between multiple project teams and in-country/regional Regulatory Affairs teams, which may include Philips associates and/or external customers.Collect registration deliverables to support product registrations and facilitate communication for any questions or answers that may arise from the business unit project team, in-country/regional Regulatory Affairs teams, or governing regulatory bodies (as communicated by the in-country team).Communicate design changes and introduce new products to in-country/regional Regulatory Affairs teams. This may involve leading regular calls with Marketing and Regulatory leadership to discuss registration status and priorities.Act as the lead for implementing new country regulations and requirements, which can include updating processes and providing training.Regularly track registration status to inform both project teams and senior management discussions.

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

Bachelor's degree or equivalent work experience.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.Minimum 2 years of experience in the medical device industryFamiliar with regulatory documents, prefer to have worked in a regulated industryExperience in supporting international registrations

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

This role is an office role/Administrative shift

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 commitment to diversity and inclusion here.

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