Siemens Healthineers, a global leader in healthcare technology, is dedicated to providing innovative medical solutions that improve lives worldwide. With a focus on diagnostic imaging, laboratory diagnostics, and medical IT, Siemens Healthineers aims to revolutionize healthcare, enhancing patient outcomes through cutting-edge technologies. Operating in over 70 countries, the company is committed to advancing healthcare through quality management and regulatory excellence.
Responsibilities in Job
As a Regulatory Affairs Analyst at Siemens Healthineers in Bengaluru, Karnataka, you will play a critical role in ensuring compliance with global regulations for in-vivo and in-vitro diagnostic medical devices. Your primary responsibilities will include:
- Regulatory Support: Work closely with the Siemens Healthineers Regulatory team to maintain and achieve legal compliance, facilitating global market access for diagnostic devices.
- International Regulatory Analysis: Support business lines and manufacturing units worldwide in analyzing and implementing international regulatory requirements.
- Communication of Regulatory Changes: Inform the global Regulatory Affairs community about any new or modified regulatory requirements, ensuring seamless adaptation.
- Documentation Creation: Assist in creating guidance documents and quality requirements for various Regulatory Affairs topics to ensure consistent compliance across all markets.
- Training Support: Contribute to the development and execution of training programs for both internal employees and external stakeholders, such as customers and regulatory authorities. This includes preparing materials on regulatory affairs topics.
Qualifications
To excel in the role of Regulatory Affairs Analyst at Siemens Healthineers, candidates should meet the following educational and professional requirements:
- A degree in natural sciences or engineering, or a master’s degree in Regulatory Affairs for medical devices.
- Over 3 years of relevant experience in Regulatory Affairs, particularly with in-vivo and/or in-vitro products.
- Familiarity with global regulatory requirements for diagnostic medical devices, with a particular focus on European regulations and international medical device standards.
- In-depth knowledge of the European Medical Device Directives and the European Medical Device Regulations for both in-vivo and in-vitro medical devices.
- Knowledge of ISO 13485, ISO 9001, and QSR standards, including experience in process analysis and management.
Skills
In addition to meeting the above qualifications, the ideal candidate should possess the following skills:
- Strong Communication Skills: Proficiency in English, both spoken and written, with the ability to communicate complex regulatory concepts effectively across diverse international teams.
- Organizational Skills: The ability to work independently, with a structured, goal-oriented approach that aligns with global regulatory objectives.
- Interpersonal Skills: Capability to navigate different cultural contexts and manage international teams with assertiveness and flexibility.
- Resilience and Motivation: Strong personal initiative, high resilience, and a flexible attitude towards adapting to changing regulatory environments.
- Willingness to Travel: The position may require occasional worldwide business trips (up to 10%).
