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Global specialty Pharmaceuticals Corporation has recently expanded their product portfolio. Having already developed a strong market in cardiology, they have bought a single dose antibiotics and anti-infectives portfolio. Therefore, they are looking to expand the team in DACH and add a Key Account Manager in Austria. They have been selling direct in Germany and Switzerland, however in Austria they used distributors. Now the strategy is changing and that is where you come in! The successful candidate will have the opportunity to build up the Austrian sales market and develop this organisation.

Company's main portfolio is focused on cardiology and antibiotics sectors. They have rapidly expanded over the last few years and built a good client base in Switzerland,Germany, Austria, UK and France. The position will be focusing on Key Accounts in the designated area (Austria) and will involve discussing products with doctors, hospitals professionals, cardiologists, purchasing departments and CEOs. It is not a role focusing on pharmacies (i.e. OTC), this is unique therapies and specialty drugs.

In this position you will be working with the already acquired customers (previously by distributors) but also 'driving' the sales in your territory and expanding the clients.

Requirements:

• 4-6 years of pharmaceutical experience, selling to hospitals
• Key Account Management experience in Pharma
• Native German, fluent English
• Strong interpersonal skills
• Great commercial awareness and strategic planning skills

For a confidential discussion about this role and to take a positive step to your next role call me, Dove Jociute at NonStop Recruitment on +49 89 210 93364 or Email:d.jociute@nonstop-devices.com and commercial.devices@nonstop-pharma.com. Apply now by sending me WORD copy of your CV.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Regulatory Affairs Manager- EU, LCM coverage for key company products, wide variety of tasks and products and a well regarded manager

I'm currently searching for a pharmaceutical regulatory affairs professional to join a small but growing global pharmaceutical company. Specifically the role will cover some of their key revenue generating products in Europe and will also have some coverage for ROW and help in creating regulatory strategies.

The company have a nice family feel in their offices and despite being a fast growing business, they also have a relaxed and mature atmosphere. It's a good role for someone wanting to further their experience in regulatory affairs but also suitable for someone already strong in post marketing regulatory who wants to have a balanced life. The manager I have known for some time and is someone with a good reputation across the market. If you could be interested 'in principle', then please contact me.

Key Responsibilities:
* Hands on input for LCM activities for Europe for MRP, DCP and CP submissions
* Input towards global RA strategy
* Coverage for areas across the life cycle including CMC, labelling and vendor management

Key Requirements:
* Life science degree
* At least 3 years experience in pharma regulatory affairs
* Experience in life cycle maintenance for EU

For a confidential discussion about this role, or to apply, then send your CV to m.beedle@nonstop-recruitment.com or call me, Matt Beedle on +41435 080817 .

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Quality Assurance Manager - IVD/Diagnostics - Switzerland

This is a growing company. Well respected in Diagnostics circles for products and automated testing of blood and serum samples, they are a global manufacturer and with HQ in scenic French Switzerland. Intent on ensuring QA staff numbers are aligned with Business needs, they are seeking (ideally) a French/English/German speaking Quality Assurance manager to take over responsibility for managing, leading, and coaching of the Quality Assurance System team with 5-7 direct reports.

Daily tasks to

• Ensure conformity and application of the Quality Management Systems across the facility.
• Manage customer audits and regulatory inspections.
• Drive strategies to continuously improve Quality Management Systems to ensure customer and regulatory requirements are met
• Collaborate actively with the business partners to develop quality culture.
• Monitor the foreseen regulatory evolutions to anticipate new requirements and plan for the future.

Typically we'd expect a degree in the Applied Sciences, Engineering, or similar, with at least 5 years medical devices industry experience and a thorough working knowledge of local standards: ISO 13485, ISO 9001 and ISO 14971, as well as FDA 21CFR820. Supervisory experience is ESSENTIAL. Being a specialist in the Diagnostics sector, product experience is useful, as is project management expertise, experience in Lean or Six Sigma projects (Green Belt certification a plus). Professionals from the Pharmaceutical sector will also be considered.

Other relevant criteria would include an analytical mindset, strong problem solving skills, creative and strategic thinking, strong ability to communicate within a multicultural environment with multiple audiences (Quality, Regulatory, R&D, Sales), and find pragmatic solutions in challenging situations.

English is essential for this role while French and German are both beneficial because of the site location and future Business plans.

Do you see your next professional challenge in this position? We look forward to receiving your application.

For more information on this vacancy, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 816, and email him at quality@quality-devices.com ahead of a confidential discussion of this opportunity. For industry news generally, and new opportunities in QA within the Medical Devices & Diagnostics sectors in Switzerland, please also join my Linked group ch.linkedin.com/in/qaswitzerland/en

KEY WORDS: Quality Assurance, QA, Compliance, Compliance specialist, Quality Engineer, Medical Devices, Switzerland, ISO 13485, ISO 9001, ISO 14971, GMP, CAPA, FDA, risk assessment, Diagnostic, IVD, laboratory, audits, instrumentation, LEAN, Six Sigma, Kaizen, 5S, IT, Corrective action, preventative action, Medical Device jobs, nonstop recruitment

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

A leading and fast growing Notified Body for the Medical Device Industry is currently looking for experienced talents within the medical devices industry to be trained and become LEAD AUDITORS!!!

Company is global business services organisation, respected world over for the development of standards; assessment of management systems; testing and certification of products and services; providing software solutions; and the delivery of training courses.

This is a great opportunity to become part of a well-renowned Notified Body that will provide you a 1 year full training period to get the skills and the knowledge you need and become a certified Lead Auditor and then be allocated in Europe and work in a specific area; but this is also the ideal opportunity for you to gain strong visibility within the medical devices industry and take on challenges and broaden your expertise in a dynamic international environment.

Moreover, besides a competitive salary, company offers 25 days of holiday, additional 13 ADV (roster free) days and a success bonus.

Your tasks:

• You will be responsible for delivering company's audit services to assigned clients in accordance with all scheme and regulatory requirements to assure timely, cost effective service delivery.
• You will be dealing with cutting-edge medical innovations with worldwide market access
• After an extensive internal training program
• you will be executing audits and processes independently;
• you will be responsible for the assessment of technical files and the auditing of quality systems of your costumers (from high innovative start-ups to large multinationals, both national and international);
• you will be acting as a linking pin and maintain frequent contact with your costumers, colleagues, external experts like physicians, contractors and authorities;

Your skills:

Interested? Get in touch!

For a confidential discussion, or to apply, send your CV to me, V.Celenza@nonstop-devices.ch.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Un grande gruppo multinazionale che opera in diversi settori e' alla ricerca, per la business unit medicale, di un CERTIFICATION ENGINEER per rinforzare il suo team di R&D e continuare la sua espansione principalmente sui mercati esteri.

Il candidato si occupa principalmente dello studio e della conoscenza approfondita delle normative tecniche di riferimento e fornisce supporto alle attività di certificazione e redazione di documentazione alla base della conformità delle normative e dei regolamenti europei ed extra-europei.

In particolare si occupa di:
* fornire supporto ai Capi Progetto e ai progettisti per individuare le normative applicabili al dispositivo in progettazione anche in base ai territori di commercializzazione previsti affinché il dispositivo progettato rispetti le normative applicabili
* mantenere un elenco aggiornato delle normative di riferimento
* definire le modalità di trasferimento dei requisiti normativi nel processo di progettazione
* redigere/modificare il fascicolo tecnico e la documentazione di prodotto in accordo con i requisiti regolatori UE/extra-UE in base ai territori di commercializzazione previsti

Requisiti:

• Diploma di laurea di tipo scientifico
• Esperienza pregressa nel settore medicale/diagnostico/dentale e conoscenza delle normative di riferimento quali: DIRETTIVA EUROPEA 93/42, ISO 13485, ISO 14971, NUOVO REGOLAMENTO DISP. MEDICI 2017/745 (MDR), redazione DHF, 510K, marcature CE
• Buona conoscenza della lingua inglese, sia scritta che orale
• Disponibilita' a trasferte presso plant produttivi esteri
• Completano il profilo proattivita' , teamworking e problem solving

Se sei convinto di avere i requisiti adatti, inviami il tuo CV in formato WORD.

Non posso assicurare un feedback riguardo la posizione oggetto di questo annuncio qualora il profilo si discosti eccessivamente dai criteri sopra elencati.

Connettiti con me su linkedin https://cz.linkedin.com/in/valerio-celenza

Non e' la posizione ideale per te? Conosci qualcuno che potrebbe essere interessato? Sentiti libero di girare questo annuncio ai tuoi contatti. Infatti nel caso in cui la persona da te indicata venisse assunta, NonStop ti riconosce un importo di 250 euro in voucher da spendere su Amazon.

Il mio cliente, una software house italiana con un network globale di sedi, per far fronte alla crescita del proprio business e' attualmente alla ricerca di un CUSTOMER RELATIONSHIP ENGINEER.

La figura entrerà a far parte del team di Customer Relationship Management diventando il punto di contatto con i principali clienti farmaceutici globali.

Si occuperà dunque di supportare il Customer Relationship Director nelle attività di analisi e risoluzione delle problematiche del cliente, interfacciandosi con gli stessi per garantirne la soddisfazione.

Si tratta di un ambiente estremamente dinamico che garantirà visibilità al candidato su scala globale e la reale possibilità di carriera parallelamente allo sviluppo del business, che attualmente registra un incremento di fatturato superiore al 50%.

Per potersi candidare sono richieste:

• Laurea in Ingegneria ( informatica, biomedica, elettronica, industriale)
• Ottima conoscenza della lingua inglese
• Ottime doti comunicative e predisposizione alle relazioni interpersonali
• Disponibilità a trasferte frequenti a livello Europeo

Se sei convinto di avere i requisiti adatti, invia il tuo CV in formato WORD.

Non posso assicurare un feedback riguardo la posizione oggetto di questo annuncio qualora il profilo si discosti eccessivamente dai criteri sopra elencati.

Connettiti con me su linkedin https://cz.linkedin.com/in/valerio-celenza

Non e' la posizione ideale per te? Conosci qualcuno che potrebbe essere interessato? Sentiti libero di girare questo annuncio ai tuoi contatti. Infatti nel caso in cui la persona da te indicata venisse assunta, NonStop ti riconosce un importo di 250 euro in voucher da spendere su Amazon.