Regulatory Professional

• As a Regulatory Professional I, the ideal candidate will be responsible to plan, prepare and submit high quality files to the authorities achieving fast approvals

• Act as an ambassador for assigned medical devices/device part of combination products
• This role involves planning, coordinating and executing the regulatory tasks as required for existing device products in accordance with the Global Regulatory Device Strategy for the defined area of responsibility in collaboration with manager and colleagues

Qualification

• More than 5 years of experience in related field along with Graduate or Post Graduate Degree Pharma, Biomedical and Engineering graduates preferred.

• Experience in handling regulatory submissions of medical devices or drug device combination products across the globe.

• Experience in handling post market changes.

• Knowledge on MDR and Current Standards is mandatory.

• Knowledge on Software as Medical Device and exposure to Notified Body audits and interactions is added advantage.

• Ability to cross collaborate and work with the teams and stakeholders from different backgrounds and culture in a Hybrid setup.