Your Job
Are you interested in being part of a team responsible for complaint handling for medical devices worldwide
Are you interested in working in a challenging regulatory environment at the interface between device and drug regulations, and willing to expand your regulatory expertise
Then you may be the person we are looking for to join our growing team in Phillips-Medisize's Global Innovation & Development Center based in Bangalore.
Our Team
We are a global regulatory team that submits and manages registrations of medical devices globally. We engage in R&D projects and life cycle management of medical devices.
What You Will Do
As a Registration Specialist, you will:
- Maintain a deep understanding of country-specific regulatory requirements.
- Execute regulatory strategy by generating country-specific regulatory documentation.
- Work in close cooperation with the project manager and the regulatory team.
- Identify and interface with local representatives worldwide.
- Review and ensure compliance of the technical documentation.
- Assemble regulatory submission packages.
- Submit required documentation to gain market clearance.
- Interact with customers and regulatory authorities to ensure regulatory clearance.
- Support development and improvement of the regulatory affairs & submission process.
- Maintain market clearance and assess change impact on approval status.
Who You Are
- Bachelor's degree in life science, engineering or equivalent.
- Proven experience in regulatory within the medical device / pharmaceutical industry.
- Experience in preparing technical documentation intended to be use for a submission.
- Willingness, and ability to quickly acquire new knowledge.
- Systematic, rigorous, and structured thinking and documentation.
- Strong organizational skills, and the ability for multi-tasking.
- Pro-activity, self-drive and goal oriented.
- Ability to work in an evolving, challenging, and multi-disciplinary environment.
- Excellent written and verbal communication skills in English.
- Proficiency with MS Office.
What Will Put You Ahead
- Experience with worldwide registration of medical devices.
- Experience in medical device approval in one or more of the following Japan, India, China, Eurasian Union, Australia & Gulf Countries, and/or Brazil.
What We Offer
Opportunity to join a growing team working in a fast pace and multidisciplinary environment.
Collaborate with the regulatory department of leading pharmaceutical companies around the world.
At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
Who We Are
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.
Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.
