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QRA Specialist for EMEA Direct Markets – F/H

Type de contrat : CDI
Région : ALLEMAGNE, Île-de-France
Niveau de formation : Bac + 4/5
Rémunération : non précisé
Famille de métier : Réglementaire

Présentation société

The Company

Headquartered in Dublin, Ohio, Cardinal Health (NYSE: CAH) is a health care services company that improves the cost-effectiveness of healthcare. As the business behind healthcare, Cardinal Health helps pharmacies, hospitals and ambulatory care sites focus on patient care while reducing costs, improving efficiency and quality, and increasing profitability. Cardinal Health is an essential link in the healthcare supply chain, providing pharmaceuticals and medical products to more than 100,000 locations each day and is also the industry-leading direct-to-home medical supplies distributor. The company is a leading manufacturer of medical and surgical products, including gloves, surgical apparel and fluid management products. Ranked #14 on the Fortune 500, Cardinal Health employs more than 50,000 people worldwide. More information about the company may be found at www.cardinalhealth.com

At Cardinal Health, we aim to be a trusted partner, offering a broad range of innovative solutions that help our customers provide cost-efficient, more effective healthcare. Join our team of 50,000 humble partners striving each day to make healthcare more efficient, providers more effective, and patients as healthy as possible.

We are currently seeking to recruit a QRA Specialist for EMEA Direct markets (mainly supporting France, Germany and Switzerland). This position can be based in either Paris or Hamburg or Dublin. Reporting to the QRA Manager for EMEA Direct Markets, you will be responsible for, but not limited to, the following:

Execute quality and regulatory processes within countries of responsibility

Develop and implement regulatory strategies and processes to ensure timely commercialization of products in compliance with applicable regulations and standards in his/her territories of responsibility

Ensure that product regulatory requirements are met in regard to EU and national laws as well as company standards in order to place and/or maintain products on the markets under his/her responsibility

Act as Local Safety Officer or QRA point of contact (depending on the market) for local authorities under his/her area of responsibility

 

Essential Functions and Responsibilities

Support the overall product registration strategies by managing and/or executing directly local product notification/registration in the assigned territories of responsibility as well as required product changes submissions

Assess regulatory impact of products changes and provide feedback on any required action in the assigned markets

Monitor local regulatory framework changes (new and revised regulation) and provide feedback on impact on local businesses (including development of strategies and actions plan)

Support on Regulatory Intelligence activities (such as, for example, participation in meetings and working groups by local industry associations – SNITEM, BVMed, Swiss Medtech)

Review and approve the content and translations of advertising materials (including digital materials and solutions) intended for the assigned markets in accordance with EU and national laws as well as company’s procedures and policies

Provide regulatory support to the Sales and Marketing department, Tenders department and other internal/external stakeholder as needed and requested

Provide continuing quality & regulatory education and dissemination of QRA information to the relevant company’s stakeholders (including, QRA trainings as needed and requested)

Support the EMEA complaint handling team on the management of complaints coming from the markets under his/her responsibility (including response to Competent Authorities queries)

Management/Execution of Field Safety Corrective Actions (FSCA) and Field Actions (FA) for the assigned territories of responsibility according to EU and national laws as well as company’s procedures and policies

Support the regional QRA team and the QRA Manager for direct markets on tasks related to company’s QMS (non-conformances, CAPA, management of suppliers and distributors, supplier and distributors audits, quality agreements, development/review of SOP etc.)

Support local business teams and QRA Manager for direct markets on both internal and external audits by regulatory bodies and competent authorities

Engage in initiatives aimed to improve QRA processes and procedures at both regional and local level

Provided limited support to other company’s function on environmental matters which apply to markets under his/her responsibility

Support business communication related issues or opportunities to next management level

Ensure personal and Company compliance with all EU, national and company regulations, policies, and procedures

Ensure compliance with Quality Procedures, Laws and Regulations of the applicable markets

Performs other duties assigned as needed

 

 

 

Descriptif du profil

Qualifications and Experience

French native speaker; fluency in German and English, both oral and written; OR

German native speaker; fluency in French and English, both oral and written

Bachelor’s Degree in Nursing, Engineering, Physical or Biological science or related field of study or related experience in the medical device industry (Master’s and/or RAC preferred)

Minimum 2 years in Regulatory Affairs within a medical device or pharmaceutical company

Consistent background and proficient knowledge of MD regulations in Europe and especially France, Germany, and Switzerland – such as for example, but not limited to, MDR 2017/745, MDD 93/42/CEE, National Medical Devices Acts, Medical Operator Ordinance, Medical Devices Adviser, French Public Health code, Bertrand Law (Advertising Materials), Market access.

Familiarity with Quality Management System and ISO 13485 is nice to have

Proven expertise in all aspects of Regulatory Affairs, good negotiation skills and ability to identify compliance risks and escalate when necessary

Good communications skills, both oral and written

Good knowledge of MS Office

Capability to work autonomously for the daily activities and ability to manage different projects and tasks at the same time

Ability to work effectively in multinational/multicultural environment and in a matrix team environment

Ability to work in team and to share experiences

Proactive approach, positive aptitude to new challenges, agile mindset

 

Postuler


manuela.benarroche@cardinalhealth.com

https://cardinalhealth.wd1.myworkdayjobs.com/fr-FR/EXT/job/France-Paris-Issy-Les-Moulineaux/QRA-Specialist-for-EMEA-Direct-Markets--m-f-x-_20107530-2



Dernière mise à jour : 19/07/2022