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Senior Regulatory Affairs Specialist
Eingestellt von Harvey Nash IT Recruitment Switzerland
Gesuchte Skills: Engineering, Client, Network
Projektbeschreibung
Regulatory Affairs Specialist
You are an expert in regulatory affairs especially in the area of medical devices? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company, is looking for you!
The focus of this position is to conduct a GAP analysis on the regulatory related technical documentation existing for China registrations through comparison with regulatory related technical documentation generated for CE marking.
In addition, the responsibilities of this position will also include:
- Assisting with reviewing of product and process documentation to ensure
compliance with change control requirements to aid determining if regulatory submissions are
required - Creation, review and maintenance of regulatory related technical documentation
- Supporting team's daily operations of regulatory processes
- Supporting maintenance of regulatory files and tracking databases to ensure prompt and
accurate access to company regulatory information concerning current, pending, and future
approvals and renewals - Providing progress of work-plans and the status of key project deliverables
Your Profile:
- Knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
- Around 5 years of experience in European Medical device industry especially with regulatory, quality or engineering
- Familiarity with Technical Documentation structure according to STED required
- Excellent skills in computer software such as MS Word, Excel, Powerpoint
- Strong Database skills
- Strong analytical skills and network thinking
- Previous experience with regulatory registrations in China would be an asset
- Excellent English spoken and written, German is an asset
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we're looking for please submit your application. We're looking forward to getting to know you.
You are an expert in regulatory affairs especially in the area of medical devices? Your profession is your passion? You're a problem solver who is looking for a new challenge? Great!
Our client, an international pharmaceutical company, is looking for you!
The focus of this position is to conduct a GAP analysis on the regulatory related technical documentation existing for China registrations through comparison with regulatory related technical documentation generated for CE marking.
In addition, the responsibilities of this position will also include:
- Assisting with reviewing of product and process documentation to ensure
compliance with change control requirements to aid determining if regulatory submissions are
required - Creation, review and maintenance of regulatory related technical documentation
- Supporting team's daily operations of regulatory processes
- Supporting maintenance of regulatory files and tracking databases to ensure prompt and
accurate access to company regulatory information concerning current, pending, and future
approvals and renewals - Providing progress of work-plans and the status of key project deliverables
Your Profile:
- Knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
- Around 5 years of experience in European Medical device industry especially with regulatory, quality or engineering
- Familiarity with Technical Documentation structure according to STED required
- Excellent skills in computer software such as MS Word, Excel, Powerpoint
- Strong Database skills
- Strong analytical skills and network thinking
- Previous experience with regulatory registrations in China would be an asset
- Excellent English spoken and written, German is an asset
We offer you a competitive salary and an interesting challenge in a well named company which will benefit your career.
If you are the person we're looking for please submit your application. We're looking forward to getting to know you.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Ingenieurwesen/Technik