Senior Regulatory Affairs Manager
Supports regulatory strategies and priorities for the International Sleep and Respiratory Care business ensuring compliance with domestic and international medical device product regulations, with a strong focus new product development. Ensures application of established policies and best practice regulatory standards within its area of responsibility for all filings, maintenance of existing product registrations and agency interactions. Has function level influence and responsibility, is a key thought leader and an expert resource.
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 requirementsMay 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 skillsFully 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 industryFamiliar with regulatory documents and international registrations, 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.
Indicate if this role is an office/field/onsite role.
About Philips
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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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