About this role
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
The Director of QRC will be a key leader within the QRC function for the Global Sales SAPAC region and will provide Regulatory and Quality leadership for the India Sales & Service Unit (IN SSU) entity. The role will also serve as the Management Representative for the IN SSU.
The incumbent is expected to have a strong understanding of India’s Quality Assurance (QA) and Regulatory Affairs (RA) requirements and will lead initiatives to ensure alignment with local Quality Management System (QMS) and product registration standards. This includes driving activities to bridge gaps in compliance, overseeing documentation, and ensuring accurate and timely filing of all required submissions, approvals, and registrations in accordance with Medical Devices Rules 2017.
The role will work closely with senior leadership to ensure that all products supplied in India meet the necessary regulatory and quality standards.
Job Responsibilities and Essential Duties
A list of the main responsibilities and percentage of time spent in each responsibility or group of responsibilities:
- A (30%) Execute the job responsibilities according to applicable Global Sales Quality Management System (GS QMS), Local Quality Management System of India, and other requirements
- B (30%) Ensure Post Market Vigilance activities are executed on a timely manner according with local and Getinge Corporate requirements
- C (25%) People Leadership
- D (15%) Product Registration on a timely & compliance manner
Strategic Planning
- Develop and implement local Quality Systems in line with Global Sales QMS
- Development and implementation of the QRC strategic plan.
Required Knowledge, Skills and Abilities
- Strong leadership and communication skills
- Resourceful and independent team player
- Mature, pro-active working attitude and able to work under pressure.
- A team player and a self-starter with strong inter-personal and presentation skills
#Li-SN2
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Other facts
About Getinge
At Getinge, we are committed to meet today's health care challenges together with health care providers and be part of improving patients’ lives around the globe.
Our offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science.
Our journey started in the village of Getinge on the Swedish west coast back in 1904. Today, our operations cover more than 40 countries and we have over 10 000 employees. Every single one of us with the firm belief that saving lives is the best job in the world.
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What you'll do
- The Head QRC will lead the Regulatory and Quality function for the India Sales & Service Unit, ensuring compliance with local Quality Management System and product registration standards. The role involves executing job responsibilities according to applicable quality management systems and overseeing post-market vigilance activities.
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