Associate Regulatory Affairs Specialist

11 hours ago

Taguig, National Capital Region, Philippines Medtronic Full time ₱60,000 - ₱120,000 per year
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.
  • Execute submission strategy on-time
  • Prepare dossier for regulatory submissions for Global Region
  • Liaise with Operating Unit regulatory affairs and stakeholders to ensure alignment on submission plan
  • Notify manager in a timely manner upon recognition of issues
  • Respond to queries from FDA/MoH
  • Keeps abreast of regulatory procedures and changes.
  • Provide on-time status about projects under their scope and all applicable regulatory activities assigned
Required Knowledge and Experience
  • Bachelor's Degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or field related experience.
  • At least 1-year regulatory experience in medical devices
  • Experience in document interpretation, queries and workflow skills is an advantage
  • Proficiency in Microsoft tools
  • Excellent communication skills
  • Ability to work as part of a team, good analytical and problem-solving skills
Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here

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