Jobbtitel: Regulatory Affairs Manager - Sweden

Arbetsbeskrivning:

Role Summary/Purpose:

In the role as Regulatory Affairs Manager you will be responsible for the National Regulatory Affairs processes for our business in Sweden. This includes responsibility for all regulatory activities that supports the compliance, registration, maintenance and promotion of GE Healthcare products in the country, as well as acting as national Pharmacovigilance and Responsible Person for the wholesaler license. In this position you will report to the Regulatory Affairs EU & EAGM Region Lead.

Essential Responsibilities:

Main regulatory point of contact with national regulatory authorities on behalf of GE Healthcare.

Responsible Person for the wholesaler license (GDP).

Local Pharmacovigilance person supporting central PV.

Responsible for ensuring local regulatory compliance and maintenance for GE Healthcare products.

Responsible person for the review and approval of promotional material in local market.

Responsible for providing regulatory support to commercial business priorities.

Responsible for preparing, maintaining and reviewing local Quality Management System including training and internal audit locally in accordance with GxP and local SOPs.

Comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this position.

Complete Quality & Compliance training within the defined deadlines.

Proactive in assessing impact of new regulations in local market

Provide national regulatory support as requested in relation to authority inspections.

Provide national regulatory input and approval related to Change Control processes for artwork.

Qualifications/Requirements:

Bachelor?s Degree, preferably within pharmaceutical sciences, and minimum significant years of regulatory affairs experience from the medical device or pharmaceutical industry or with medical product regulatory agencies, with experience in dealing directly with regulatory authorities.

Ability to prioritize, plan and evaluate deliverables.

Ability to work independently with minimal daily supervision on projects and activities.

Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner.

Fluent in Swedish.

Experience using spreadsheet and presentation software.

Desired Characteristics:

Ability to interact with, lead and work with multiple functions/stakeholders.

Team and business oriented ? collaborate with others to solve business problems.

Clear thinker and flexible.

Strong PC-skills.

Arbetsgivare Namn: GE Healthcare

Arbetsgivare adress: Vendevägen 89 18211 Danderyd

Form av kontakt:
titel : telefon 1: () telefon 2: () mobil: e-post:

Jobb kort beskrivning:
Engineering professionals not elsewhere classified

Land: Sweden

Område: Stockholms län

Avtalstid: Permanent

Typ av kontrakt: Full time

Källa till jobberbjudande: Public Employment Service of Sweden(AMS)

Hur man ansöker: Other - see free text