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| Job Opportunities |
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You know the direction you want to take.
And after relevant professional experience can very clearly imagine what you want your job to be. You think straight, even if not everything is planned down to the very last detail.
It's not your style to wait-and-see; instead you find solutions and take the initiative. Then join Bien-Air and take responsibility from day one. Your future career at Bien-Air is
open for your development: because you actively help to shape your own prospects. |
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| Details |
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| Position |
REGULATORY AFFAIRS MANAGER |
| Date |
16/07/2010 |
| Language |
FR, EN, DE |
| Location |
Switzerland - Bien-Air Dental - Biel/Bienne |
| Job description |
- Ensure the application of regulatory requirements in all processes, in
cooperation with the Quality System Manager
- Identify and communicate the relevant regulatory requirements that apply to either new or modified products
- Ensure compliance of device technical files
- Compile and adapt the necessary product technical documentation to fulfil requirements from different jurisdictions
- Address regulatory requests from customers
- Cooperate with distributors and subsidiaries on product registration
- Liaise with the relevant regulatory bodies and competent authorities
- Raise awareness and train staff in regulatory issues relative to medical devices
- Monitor regulatory activities (regulations, standards, guidelines) relevant to Bien-Air Dental SA’s products
- Implement post-marketing surveillance activities, including vigilance of medical devices
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| Knowledge |
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University degree or equivalent
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Confirmed experience in a similar position
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Excellent written and spoken level in English, and good spoken level in French
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Any other languages would be an asset
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Excellent communicator, rigorous and structured
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| Contact |
+41(0)32.344.64.64 sp@bienair.com |
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 More information |
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