Regulatory Affairs Analyst
Siemens Healthineers
Date: 1 week ago
City: Bengaluru, Karnataka
Contract type: Full time
Your tasks and responsibilities:
> You will be closely aligned with the Siemens Healthineers Regulatory team to support required activities for our employees to achieve and maintain legal compliance as a prerequisite for global market access for in-vivo and in-vitro diagnostic medical devices
> You will support the Business lines and manufacturing units in different countries for the analysis and implementation of international regulatory requirements
> You communicate new or changed regulatory requirements to the global Regulatory Affairs Community of Siemens Healthineers
> You support in the creation of quality requirements and guidance documents for Regulatory Affairs topics
> You support the creation and execution of worldwide training for our employees as well as external institutions (e.g., customers, authorities), including the creation of training materials on Regulatory Affairs topics
Your qualifications and experience:
> You have a degree in natural sciences or engineering; alternatively, you have a master's degree in Regulatory Affairs for medical devices
> You have > 3 years of relevant professional experience in the field of Regulatory Affairs for in-vivo and/or in-vitro products
> You are familiar with the global regulatory requirements for in-vivo and/or in-vitro products
> You also have country-specific regulatory knowledge for other countries, especially Asian and Eastern European countries
> You have detailed knowledge of the European Medical Device Directives and the European Medical Device Regulations for in-vivo and/or in-vitro medical devices
> You have very good knowledge of international medical device standards
> You have well-founded knowledge and experience in QM systems (based on EN ISO 13485, EN ISO 9001, QSR) in process analysis, process management and process optimization
Your attributes and skills:
> You can demonstrate your strong communication skills with your negotiation-level English language skills in speaking and writing
> You have an independent, structured, goal-oriented working style, are assertive, and know how to use your intercultural experience to interact with different cultures and personalities in international teams and manage them
> Your personal strengths include strong motivational ability, high personal initiative, as well as high resilience and flexibility
> In addition, you are willing to undertake worldwide business trips (max. 10%)
> You will be closely aligned with the Siemens Healthineers Regulatory team to support required activities for our employees to achieve and maintain legal compliance as a prerequisite for global market access for in-vivo and in-vitro diagnostic medical devices
> You will support the Business lines and manufacturing units in different countries for the analysis and implementation of international regulatory requirements
> You communicate new or changed regulatory requirements to the global Regulatory Affairs Community of Siemens Healthineers
> You support in the creation of quality requirements and guidance documents for Regulatory Affairs topics
> You support the creation and execution of worldwide training for our employees as well as external institutions (e.g., customers, authorities), including the creation of training materials on Regulatory Affairs topics
Your qualifications and experience:
> You have a degree in natural sciences or engineering; alternatively, you have a master's degree in Regulatory Affairs for medical devices
> You have > 3 years of relevant professional experience in the field of Regulatory Affairs for in-vivo and/or in-vitro products
> You are familiar with the global regulatory requirements for in-vivo and/or in-vitro products
> You also have country-specific regulatory knowledge for other countries, especially Asian and Eastern European countries
> You have detailed knowledge of the European Medical Device Directives and the European Medical Device Regulations for in-vivo and/or in-vitro medical devices
> You have very good knowledge of international medical device standards
> You have well-founded knowledge and experience in QM systems (based on EN ISO 13485, EN ISO 9001, QSR) in process analysis, process management and process optimization
Your attributes and skills:
> You can demonstrate your strong communication skills with your negotiation-level English language skills in speaking and writing
> You have an independent, structured, goal-oriented working style, are assertive, and know how to use your intercultural experience to interact with different cultures and personalities in international teams and manage them
> Your personal strengths include strong motivational ability, high personal initiative, as well as high resilience and flexibility
> In addition, you are willing to undertake worldwide business trips (max. 10%)
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