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Regulatory Affairs Specialist
Information about the position
Job description, responsibilities and duties
The role will assure timely notifications of medical devices and all tasks connected with. Provide support in RA matters to ensure compliance and business continuity.
Main responsibilities:
- Ensure regulatory clearance of medical devices being in product portfolio of client MDs within timelines. Coordination and preparation of product notifications and strategies. Managing product submissions and communication with national health authority.
- Provide regulatory support to Tender Management, Health Economics & Reimbursement, Business, Distributors and Franchises.
- Provide communication and updates to management regarding regulatory affairs and deliver RA trainings to local clusters.
- Ensure timely communication and feedback on problems and events related to RA compliance
- Collaboration in process of RA restrictions removal in distribution center.
- Responsibility for approvals in systems linked to job duties and maintaining RA databases.
- Establish and keep relationships with business partners and internal/external RA groups (MD) Franchise and DC
- Monitor legislative situation, lead projects related to compliance and ensure that RA SOPs are updated and followed.
- Support deployment of client Standards into LOC QMS related to RA aspects.
- Collaborating with other departments to coordinate development of procedures, documents and controls to ensure compliance in a timely manner. Review and disposition document changes within areas of expertise per applicable procedures
Contract for 1 year ( possibility of prolongation )
Company on whose behalf the position is being filled
Pharmaceutical company
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Language skills
Other knowledge
Microsoft Word - Advanced
Number of years of experience
Personality requirements and skills
- Demonstrable knowledge of Regulatory, understanding of Medical Devices environment.
- At least 1 year experience in Regulatory Affairs environment.
- Excellent interpersonal skills - build and maintain relationships with internal and external partners.
- Detailed planning and execution to achieve accurate and timely results.
- Sense of importance and mission of the role.
Advertiser
Brief description of the company
The company is a holder of a licence to offer recruitment services.
Number of employees
Contact
Ak budete životopis zasielať emailom, k životopisu, prosím, pripojte aj nasledujúci text, bez ktorého nebude možné vašu žiadosť ďalej spracúvať:
Svojou reakciou na pracovnú ponuku, v súlade so všeobecným nariadením o ochrane údajov 2016/679 (ďalej len „GDPR“) vyhlasujem, že som si prečítal(a) a porozumel(a) obsah dokumentu “Oznámenie o ochrane osobných údajov”, ktorý je k dispozícii na https://www.manpower.sk/ochrana-osobnych-udajov/, a týmto beriem na vedomie, že:
i) moje osobné údaje budú spracúvané spoločnosťou ManpowerGroup Slovensko s.r.o., so sídlom Landererova 12, 811 09 Bratislava, Slovenská republika, IČO: 35958898, zapísaná v OR OS Bratislava I, oddiel: Sro, vložka číslo: 37879/B (ďalej len „Prevádzkovateľ“), v plnom súlade s nariadením GDPR a ostatnými platnými právnymi predpismi, a to spôsobom a v rozsahu uvedenom v dokumente “Oznámenie o ochrane osobných údajov”;
ii) ak si ako vlastník údajov budem žiadať získať viac informácií o spracovaní svojich osobných údajov alebo budem si chcieť uplatniť svoje individuálne práva, môžem kontaktovať Prevádzkovateľa buď prostredníctvom kontaktných údajov uvedených v “Oznámení o ochrane osobných údajov”, alebo cez online formulár “Podanie žiadosti subjektu údajov” na https://www.manpower.sk.
Ako nás kontaktovať
Ak máte akékoľvek otázky či pripomienky k tomuto “Oznámeniu o ochrane osobných údajov” alebo požadujete si uplatňovať svoje individuálne práva, môžete nás kontaktovať písomne buď na adrese sídla spoločnosti ManpowerGroup Slovensko s.r.o., Landererova 12, 811 09 Bratislava, Slovenská republika, alebo prostredníctvom online formuláru “Podanie žiadosti subjektu údajov”, ktorý nájdete tu.
If you send your CV by e-mail, please, add the following text (below) to the CV. Otherwise, your application will not be possible to process further.
By responding to the job offer, in accordance with General Data Protection Regulation 2016/679 (hereinafter "GDPR"), I declare that I have read and understood the content of the document "Personal Data Processing Notice", which is available at https://www.manpower.sk/ochrana-osobnych-udajov/?lang=en, and, I hereby acknowledge that:
i) my personal data will be processed by ManpowerGroup Slovensko sro, with its registered office at Landererova 12, 811 09 Bratislava, Slovak Republic, IČO: 35958898, registered in the Commercial Register of OS Bratislava I, section: Sro, file number: 37879 / B (hereinafter referred to as " the Data Controller “), In full compliance with the GDPR Regulation and other applicable legislation, in the manner and to the extent set out in the“ Personal Data Processing Notice”;
ii) if, as a data owner, I request more information about the processing of my personal data or I want to exercise my individual rights, I can contact the Data Controller either through the contact details provided in the "Personal Data Processing Notice" or through the online form "Submission of data subject request”
How to contact us
If you have any questions or comments about this "Privacy Notice" or wish to exercise your individual rights, you can contact us in writing either at the registered office of ManpowerGroup Slovensko sro, Landererova 12, 811 09 Bratislava, Slovak Republic, or via the online form. "Submission of data subject request", which can be found here.
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