International Regulatory Affairs Specialist
il y a 1 semaine
Job Title:
International Regulatory Affairs Specialist
International RA Specialist
Philips Image Guided Therapy Corporation
Zaventem, Belgium
In this role, you have the opportunity to
- Be recognized as a key talent in international regulatory filings and procedures (excluding USA and Japan). Potential to transition into an internal Subject Matter Expert in a regulatory geography and knowledgeable in a 2nd geography.
- Be considered a key regulatory point person enable the regulatory compliance in Markets where Philips Image Guided Therapy products are commercialized.
- Be an impactful member of the Regulatory Affairs team and trusted by management as an independent regulatory team member on multiple project simultaneously.
- Support multiple projects, function on a multigeography basis, prioritize, conduct team meetings, and meet project deadlines.
You are responsible for
- Preparing regulatory strategies for new devices, new registrations and reregistrations/notifications due to product changes, regulatory changes, changes in Go2Market model. Clearly communicates strategies to RA management and core teams.
- Preparing and submitting product registration files to obtain or to keep marketing approval and import licenses per local regulatory requirements for CE marked/FDA cleared devices in the countries of distribution in order to ensure that our products comply with the regulations
- Expanding your regulatory knowledge of the geographies you are responsible for, liaising with local Philips Entities, Distributors, local Trade Associations and other sources of Regulatory Intelligence
- Identifying Process optimization to strengthen the International Regulatory Department.
- Preparing regulatory filings for new products, as well as significant post market changes. As necessary, reviews complex regulatory issues with RA manager.
- Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
- Able to identify risks within regulatory strategies and clearly communicate risks to projects teams and RA management
- Able to professionally negotiate and lead meetings with internal and external customers (Marketing, R&D, Markets, Distributors). All significant issues are negotiated with the RA Manager.
- Following Quality System procedures to ensure compliance with all other applicable regulations.
- Maintaining proficiency in broad, regional regulatory requirements. Develop general strategies on more effective interactions with government agencies and agency personnel.
- Assisting the RA Manager with training of more junior specialist staff.
You are a part of
You are part of a motivated team, which enables the commercialization of IGT-D medical devices in compliance with international regulations.
To succeed in this role, you should have the following skills and experience
- EU work authorization is a precondition of employment.
- BS degree in relevant field. (BS, MS, or PhD in Engineering or Science preferred.)
- 35 years of medical device experience with BS degree and work experience in Regulatory Affairs, or 3 years of medical device experience with MS degree and work experience in Regulatory Affairs, or 3 years of Regulatory Affairs experience with PhD in Engineering/Science.
- Excellent communication both written and verbal as well as have experience with communication and presentations to senior leadership.
- Demonstrated experience in multiple types of International regulatory submissions
- Must have working knowledge of FDA, ISO 13485, EU MDR, and other applicable regional regulations for handling complaints, reporting incidents, and implementing corrective and preventative actions.
- Ability to makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines.
- Knowledge of PC hardware/software, documentation and archives (Proficiency in Microsoft Office Suite, particularly Word and Excel)
- Languages: English (written and spoken), knowledge of other languages is an asset
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide.
Succeeding in this global role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise.
We also believe that we are at our best as a company when you are at yours as a person.
Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.Why should you join Philips?
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across
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