Add office photos
All Filters
46 Siemens Healthcare Jobs
Regulatory Affairs Analyst
Siemens Healthcare
posted 16d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
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 masters 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%)
Employment Type: Full Time, Permanent
Read full job descriptionPrepare for Regulatory Affairs Analyst roles with real interview advice
What people at Siemens Healthcare are saying
What Siemens Healthcare employees are saying about work life
based on 268 employees
Flexible timing
Monday to Friday
No travel
Day Shift
Siemens Healthcare Benefits
View more benefits
Compare Siemens Healthcare with
GE Healthcare
Compare
Siemens Healthineers
Compare
Toshiba Medical Systems
Compare
AGFA HEALTHCARE INDIA
Compare
Varian Medical Systems
Compare
Medtronic
Compare
Roche Diagnostics
Compare
Optum
Compare
Paras Hospital
Compare
UnitedHealth
Compare
Redcliffe Labs
Compare
Pristyn Care
Compare
Pacific BPO
Compare
Metropolis Healthcare
Compare
Baxter International
Compare
Columbia Asia
Compare
Care Hospital
Compare
Advantmed
Compare
Nephroplus
Compare
Portea Medical
Compare
Share an Interview