Regulatory Operations Specialist

  • Company:
    Philips
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    5 hours ago
  • Category:
    General

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**In this role, you have the opportunity to:**

Develop and implement global regulatory strategy and roadmaps through deep understanding of the summary competitive market landscape, regulatory / legislative initiatives, and product marketing strategy.

**You are responsible for:**

+ Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards.

+ Prepare regulatory submissions for new products, product changes, and re-registrations as required.

+ Maintain registration information and obtain re-registration approvals in advance of license expiration to ensure no disruption in product availability.

+ Coordinate testing required to support regulatory submissions.

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

+ Assist in regulatory process with Distributors in South LatAm countries for Health System.

+ Prepare and all licenses request to ANMAT and support distributors in rest of South Latam.

+ Register, assist and follow up on South LatAm regulatory process (Philips + Distributors).

+ Maintain updated regulatory Database with new regulations.

+ ANMAT – Manage creation of VEP for payments to ANMAT.

+ Keep updated the tools used by Philips to monitor NPI for regulated SL countries

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

+ Bachelor’s degree and> 5-8 years of experience within the regulatory area, in product registration (Anmat).

+ Experience in healthcare (Medical Devices) or pharmacy industry.

+ Experience working in a business with complex market/channel structures

+ Problem – solving skills

+ Set priorities per own work & planning.

+ Advanced English (Is a must). Will have frequent communication with the factories of China, Holland, USA, India, Singapore, others.

**Your team**

Based in **Buenos Aires** , will act as Regulatory Operations Specialist in the Health Systems Industry. This position reports directly to the Quality & Regulatory Manager.

**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 .

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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