For our dynamically growing Abbott Rapid Diagnostics Division ARDx we are looking for an ambitious, detail-oriented professional to join our team in Prague as a Regulatory Affairs Specialist. This will be a regional role covering the area of Eastern Europe and Turkey.

Primary Objective of Position

• Follow up on all new EU, local EE and Turkish legislation.
• Assurance the compliance of all business activities with all applicable local legal requirements and European directives and reports all noncompliance issues immediately to the direct and General Manager for corrective action.
• Addresses all contacts and enquiries from the Competent Authorities.

Main responsibilities:

• Managing full registration of all products in collaboration with manufacturer and with/without local vendor for registration according to the Global Submission Process and all local requirements.
• Registration dossier preparation in accordance with the local requirements (documents creation, interaction with the manufacturer, consulting and translating agencies).
• Establishing and maintaining good working relationships with all involved regulatory and other institutions.
• Identify new regulations or updates of existing regulation in EE and Turkey.
• Maintain a product re-registration/notification/approval due changes on manufacturing site according to adopted registration strategies (and company's high ethical standards policy).
• Responsible for in time vigilance reporting according local legislation.
• Obtaining other required documents (declarations of conformity, import permits, licenses etc.);
• Supporting local team on regulatory issues;
• Keeping up-to-date with changes in regulatory legislation and guidelines;
• Analyzing complicated information, including trial data;
• Support in outlining requirements for labelling, storage and packaging;
• Assist in negotiating with regulatory authorities;
• Providing advice about regulations to manufacturers/scientists.

Requirements:

• University degree in a related field (pharmacy, biology, chemistry, medicine, engineering, quality, law etc.);
• Scientific background preferred
• At least 2-3 years of experience in Regulatory Affairs (medical equipment - preferably, pharmaceuticals, chemical products)
• Good knowledge of EU, EE legislation
• English – fluent written, spoken is a must
• Knowledge of MS Office (Word, Excel)
• Used to work in remote teams
• Personality: team player, perfectly self-organized, attentive to details, enthusiastic, quick learner
• Ability to work with big amount of information

How we will reward you
As you’d expect from a global healthcare company, we offer stable employment conditions, long-term career perspectives and a fantastic range of benefits including competitive salaries and bonus potential, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme.