Senior International Regulatory Affairs Specialist
Senior International Regulatory Affairs Specialist
In this role, you have the opportunity to
- Be an impactful member of the Regulatory Affairs (RA) team and trusted by management as an independent regulatory core team lead on project teams.
- Support multiple projects, function on a multi-geography basis, prioritize, conduct team meetings, and meet project deadlines.
You are responsible for
- Configure and deploy document management processes and tools related to global regulatory submissions
- Compile Regulatory filings for EU MDR and roll them out in Worldwide.
- Be recognized as a key talent in the implementation of the European Medical device Regulation 2017/745 in a Medical Device Multinational.
- Establish procedures to identify and implement new ways of working across sites and geographies.
- Be considered a key regulatory contact person enabling the regulatory compliance in internationally.
- You are responsible for
- Develop, configure and deploy a new integrated solution used for the publication process of the EU MDR technical Documentation across sites in a standard way and enable its international deployment
- Implement and establish new regulatory processes for the creation and deployment of regulatory registration packages for International Registrations.
- Preparing product registration files in International Markets with local representatives and follow-up until obtaining local approvals and shipping authorization.
- Expanding your regulatory knowledge to optimize International Regulatory Submissions
- Able to identify risks within regulatory strategies and clearly communicate risks to projects teams and RA management
- Following Quality System procedures to ensure compliance with all other applicable regulations.
- Maintaining proficiency in broad, regional regulatory requirements.
- Assisting the RA team with training
You are a part of
As a result of Philips renewed dedication to Quality, it has recently restructured its organization to ensure you and your department have clear collaboration with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
- US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa
- BS degree in relevant field. (BS, MS, or PhD in Engineering or Science preferred.)
- 7+ years of medical device experience with BS degree and work experience in Regulatory Affairs
- 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 in all of the following markets: China, Korea, Saudi Arabia, Brazil, Russia, Australia, Colombia, Singapore, India, Taiwan, Malaysia.
- Must have working knowledge of FDA, ISO, EU, 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 the health continuum . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it's like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog . Once there, you can also learn about our recruitment process , or find answers to some of the frequently asked questions .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.
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