|Lokalita: CAERPHILLY, MID GLAMORGAN||Mzda: 27000 - 29000 GBP Per Annum|
|Sector: Scientific||Typ pozice: Práce na živnostenský list|
|Shift Type: N/A||Aplikace: N/A|
|Přidáno před: 2 měsíci||Referenční číslo: 3054902|
* To support the Regulatory Affairs in preparation of documents and submissions to ensure the appropriate licensing, marketing and legal compliance of the company’s products, with all required regulations.
* To support the Regulatory Affairs from a scientific, or legal and business issue, to ensure products, which are developed, manufactured or distributed meet the required legislation.
* To support and co-ordinate the approval and registration of the products, in different countries.
Note: In addition to these functions, employees are required to carry out such other duties as may reasonably be required.
* Keeping abreast of international legislation, guidelines and customer practice - ISO 13485, CFR 820, MDD 93/42/EEC.
* Develop international product registrations and provide guidance to product development teams regarding data and information required to prepare such registrations.
* Maintenance of Product Folders incorporating test reports, certificates, letters, notarisations etc.
* Keeping up-to-date with the Company's product range. Supporting submissions of registrations, licenses and renewals to strict deadlines ensuring the product certification matches product code/scope.
* Supporting Regulatory team involved with the development of new products to enable completion of DMR.
* Support regulatory inspections by Notified Bodies e.g. SGS, MHRA.
* Support in specifying storage, labelling and packaging requirements.
* Supervise document control (hub); files/requests/training & development e.g. Sage.
Skills, Qualifications & Experience
* Degree (or equivalent) in Biomedical Science, Biotechnology or related Life Sciences discipline.
* Relevant degree areas do include Physical Sciences, Mathematical Sciences, Applied Medical and Life Sciences. In particular, Medical physics & Biomedical Science and related subject areas are all suitable for the position.
* Research experience is valuable with prior experience or knowledge of clinical work; toxicology; manufacturing techniques; relevant aspects of the law.
* Quality Compliance, Document Control and Regulatory Submission experience with an ISO 13485 environment.
* Customer Complaints & Pharmacovigilance experience are advantageous.
* Understanding and experience of working within the Medical Device Industry.
Applicants will need to show evidence of the following:
* Analytical and problem-solving skills.
* Written and oral communication, and presentation skills.
* Considerable understanding of both legal and scientific matters.
* The ability to work to strict deadlines.
* The confidence to report to management.
* Strong negotiation and arbitration skills.
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