Regulatory Affairs Specialist at Thermo Fisher
Regulatory Affairs Specialist at Thermo Fisher
Thermo Fisher Scientific
Job description
Thermo Fisher Scientific are looking for Regulatory Affairs specialist role at Bengaluru. This would be a great opportunity for healthcare professionals.
Company Description
Thermo Fisher Scientific is the world leader in serving science. With more than $44 billion in annual revenues, over 125,000 employees globally, and driven by the mission to enable customers to make the world healthier, cleaner and safer we provide unrivalled solutions in life science technologies, analytical instruments, specialty diagnostics and laboratory products.
Job Summary
As Regulatory Affairs Specialist you will ensure life science, medical devices, IVDs or clinical trial products meet the stringent requirements of global and regional health authorities. You will work in a highly regulated industry to ensure effective liaison between product/project teams and regulators.
Key Responsibilities
The key responsibilities of Regulatory affairs specialist are:
Supporting documentation under EUCTR guidance.
Managing deliverables related to client regulatory requirements.
liaising with and providing support to internal and external clients for tracking and updating project plan, providing support to projects.
Maintaining an up to date knowledge of SOPs, client SOPs/directives and relevant regulatory guidelines.
Identify client requirements and ensure they are met in line with project timelines.
Work with other team members, functional areas and/or management to deliver the final product, and overcome any issues or barriers.
Provide support with project specific tasks, documentation and managing projects. Provide support with reporting to management.
Support with bid and proposal preparation. Generate, track and analyse data to support proposals, revisions, contract changes and bid defences.
Educational Qualification
Educational qualifications required for Regulatory affairs specialists are:
Bachelor's or Master’s degree in healthcare or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
Skills Required
Skills required for Regulatory affairs specialist are:
Knowledge of medical device, IVD, or chemical regulations (such as FDA, EU MDR/IVDR, ICH guidelines, or regional compliance like China chemical regulations).
Understanding of GMP (Good Manufacturing Practice), ISO 13485, and general Quality Management Systems (QMS).
Experience with regulatory submissions, clinical trial applications (CTA), lifecycle management, and document management systems.
Strong technical writing skills.
Proficiency in Software & Tools.
Holding or pursuing a RAC (Regulatory Affairs Certification) is considered a strong advantage.
Salary Structure
The average salary range for a Regulatory Affairs Specialist at Thermo Fisher Scientific is ₹9.1 Lakhs to ₹12.3 Lakhs per year.
Career Development
As a Regulatory Affairs Specialist you will develop your knowledge by working with a wide range of products globally. Through RAC certification support and other learning opportunities. There is a clear career path from Specialist to Senior and Manager roles and we have a strong commitment to moving people internally. This means you can create a dynamic career with us.
How to Apply
Go to our jobs page and search for Regulatory Affairs Specialist at Thermo Fisher Scientific.
Click on the role to see further details.
Complete your details and upload your CV.
Submit your application.
Education
Bachelor's Degree
Key Skills
Need a resume for this job?
Start from our Regulatory Affairs resume template, with example points and skills ready to click in. ATS-friendly, and downloads as a PDF.
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.