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| Company: |
Optima Recruitment Europe |
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| Job Title: |
Regulatory Specialist |
| Job category: |
Pharmaceutical |
| Job Location: |
Zdar nad Sazavou - Czech Republic |
| Job Description: |
For our client, a global organization providing a broad range of medical solutions, we are looking for a suitable candidate for the position of Regulatory Specialist.
Main tasks:
The Regulatory Affairs Specialist is responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for the products.
Responsibilities:
1. Supporting R & D Projects
Participation in project work such as new product introductions, changes to existing products and processes and other regulatory/company projects as required.
2. Change Control- Documentation preparation and review
Preparation of internal reports and change control documents, and the review of documents for potential impact on regulatory submissions.
3. Product Registration/CE Marking
Preparation of registration documents for submission to Regulatory bodies/agencies to obtain and maintain regulatory and CE mark approvals for the products
We require:
- education: Graduate, Lifesciences or Engineering.
- knowledge of ISO 13485:2003, Council Directives 93/42/EEC (Medical Device Directive) and 2007/47/EC is a must,
- knowledge of FDA s 21 CFR Part 820 (Quality System Regulation) and the Canadian Medical Device Regulations, 2006 is an advantage,
- experience: ideally 1-2 years industrial experience preferred, in the healthcare industry is an advantage, working in Regulatory Affairs, Quality Assurance, Product Development, Document Control or Compliance areas.
- further requirements: - Excellent written and communication skills,
- Project Planning and Organisation skills,
- Good problem solving skills,
- Good administrative / organisational ability with attention to detail,
- Decision Making skills,
- Highly motivated and a self starter,
- Proficiency in MS office products
- Fluency in English
We offer:
* Interesting job in a very stable worldwide company
* Comfortable working environment
* Great salary
* Benefits
Locality: Žďár nad Sázavou
Personal data provided to Optima Recruitment EUROPE, s.R.O., IČO: 264230022 for the purpose of employment transmission are handled according to law č.101/2000Sb. Provided data are kept in the database for an essential term of employment transmission or till the withdrawal in writing. These data may be provided to the third party just after the permition of the provider. The enactment of §12 a 21 zákona č.101/2000Sb.Governs your right to information of handling with personal data, explanation, updates as well as disposal of it. |
Language Requirements: |
English-Very Good |
| Employment Type: |
Full Time |
| Yearly Salary: |
Unspecified |
| Posting Date: |
2009-07-27 |
| Level of Education: |
Unspecified |
| Years of Work Experience: |
3 to 5 Years |
| Company: |
Optima Recruitment Europe |
| Contact Name: |
Optima Recruitment Europe |
| Contact Phone: |
+420224162700 |
| Contact Fax: |
+420224162709 |
| Preferred Method of Contact: |
No Preference |
| Preferred Language of Resume/Application: |
English |
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