Regulatory Affairs Executive
Regulatory Affairs Executive
GE Healthcare
Job description
Are you looking to advance your career in regulatory relations in the medical technology industry? Explore the Regulatory Affairs Executive position at GE HealthCare.
Company Description
GE HealthCare is a multinational medical technology company that develops medical equipment, digital solutions, and related technologies. Its work is dedicated on aiding healthcare professionals with medical imaging, diagnostics, patient monitoring and other healthcare solutions. The organization strives to enhance patient care through the integration of clinical experience, technology, and innovation.
Job Summary
The Lead Specialist- Regulatory Affairs role based in Bengaluru will provide support to regulatory efforts for assigned healthcare goods in multiple markets. The responsibilities of the Regulatory Affairs Executive include: producing regulatory submissions, aiding with product registrations and filings and supporting pre-market and post-market compliance efforts. The Regulatory Officer will cooperate with Regulatory Affairs colleagues and cross functional teams to evaluate applicable rules, assess regulatory requirements, keep correct records and support product market access and ongoing compliance.
Key Responsibilities
Support regulatory activities across the whole product lifecycle including product registration, submission preparation and ongoing compliance needs.
Interpret and apply appropriate nation specific and regional regulations, standards, guidelines and internal procedures.
Support global registration planning, regulatory filings, quality system audits, notified body interactions, and program execution.
Prepare, review, revise and organize technical documents and supporting information for regulatory submissions.
Research regulatory requirements and estimate the effects of regulatory or standards changes on assigned products and markets.
Assistance in arranging for market entry including determining rules, potential restrictions, your requirements, and timing.
Maintain technical knowledge of assigned products including intended use, design, performance characteristics and context of manufacture.
Identify regulatory questions, risks and potential compliance issues and consult management or subject matter experts as necessary.
Work with colleagues in Regulatory Affairs, Quality Assurance, Engineering, Manufacturing, Clinical, Marketing and other relevant disciplines.
Educational Qualification
Bachelor's degree from an accredited university.
Qualification in science, engineering, health sciences, legal studies, regulatory affairs, quality or similar discipline desirable.
A relevant professional experience is a must.
Skills Required
Experience with regulatory affairs principles and compliance needs.
Ability to understand technical documentation and follow processes as prescribed.
Excellent English written and verbal communication abilities.
Research and analytical skills to analyze rules and evaluate compliance issues.
Good decision making skills, problem solving.
Project co-ordination, planning and organization skills.
Ability to manage several priorities and deadlines.
An eye for detail and a devotion to accurate recordkeeping.
Stakeholder communication and collaboration abilities.
Flexibility, responsibility, honesty and the ability to work independently as required.
Salary Structure
The average salary of a Regulatory Affairs Lead Specialist in India ranges between ₹13.8 Lakhs to 15 Lakhs per year.
Career Development
This position as a Regulatory Officer will give you the opportunity to develop regulatory knowledge, experience healthcare product compliance and work with cross-functional teams. Over time, professionals may build the abilities to go into senior regulatory affairs, regulatory program management, or more general quality and compliance roles.
How to Apply
Check out our job site and search for Regulatory Affairs Executive vacancy.
Review the whole job description, qualifying criteria, and location details in the listing.
Enter the essential details and submit your updated resume.
Review your application and submit.
Education
Bachelor's Degree
Key Skills
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.