Regulatory Affairs Specialist (m/w)

Lawrence Harvey

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Job ID :

12971


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Other


Address 1 :

Western Europe,--Zurich,Zürich,


Key Skills :

Regulatory Affairs, MDR, IVDR, Project Management, MDD 93/42/EC, MDR 2017/745


Salary :

£73207 - £84766 per annum


Date Posted :

19 Sep, 2018



Company Name :

Lawrence Harvey


Location1 :

Zürich




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

100.00%





Description

EU MDR/IVDR Project - Regulatory Affairs

Would you like to be responsible for assisting the team with regulatory implementation of EU MDR.

This position requires a good understanding of medical devices and their use as well as an understanding of the regulatory framework in Europe, MDD 93/ 42/EC and MDR 2017/745.

This position specifically supports implementing the EU MDR globally for our client through execution according to the project plan.



Your responsibilities:



* Applies regulations to business practices and provides regulatory input, advice and guidance as needed



* Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products, under the new EU MDR



* Write, refine, track and coordinate Regulatory corporate procedures for harmonization of implementation of EU MDR



* Support in localization of procedures (from Corporate procedures to Local procedures)



* Respond to requests from different Manufacturers as needed



* Supports Sr. Specialist on coordination of impact assessment of implementation of EU MDR in international licenses, closely with Regulatory Specialists from different regions, and supporting supply chain planning



* Consolidate frequent asked questions in the area of regulatory Affairs to support harmonized communication and clarifications



* Support on preparing materials for training and guidance to Regulatory Affairs professionals, supporting implementation of EU MDR



* Follows regulatory affairs policy and proceduresPlanung, Koordination, Begleitung und Durchführung von Risikobewertungen nach ISO 14971



Qualification:



* Strong writing, communication, and interpersonal skills



* Strong attention to detail



* Ability to multi-task, work with rapid changes, and balance competing priorities



* Knowledge of overall medical devices business and regulatory environments



* Ability to learn and stay abreast of European/MDR-related regulations pertinent to medical devices and biologics.



* Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels



* Knowledge of EU and other regulatory body regulations



* Ability to identify risk in Regulatory strategies



* Strong problem solving and analytical skills



* Effective negotiating skills



* Self-motivated and capable to work in a diverse, fast-paced and dynamic environment



* Basic computer skills, including Microsoft Office Suite



* Bachelor's degree required; concentration in life sciences, technical/engineering or related field, preferred



* A minimum of 2-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required



* A combination of education and experience may be considered



* Travel up to 5%



SciPro is a people business. We specialise in sourcing, advising and introducing highly skilled life sciences candidates to our client partners across the globe, helping them to achieve their business goals. The art of recruitment isn't solely about filling jobs, it's about matching people with people and creating harmonious and successful working environments. As a leading staffing specialist with offices in the UK, Europe and North America our biggest USP is representing candidates of all levels across Research & Development, Operational Excellence & Performance, Manufacturing Quality, Compliance, Regulation, Data Management, Cost Optimisation and Innovation. We pride ourselves on being able to deliver to almost every requirement in your business, in any location you need it.



Your personal Consultant:

Petra Ognjenovic
Lead Consultant Switzerland

For questions you can reach me any time by
phone +41 43 508 9217 or email p.ognjenovic@sciproglobal.de.


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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