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Ra/qa Specialist

Clasificación del trabajo: Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Físicos, químicos y afines : Químicos.

Erityisasiantuntijat : Luonnontieteiden ja tekniikan erityisasiantuntijat : Luonnon- ja geotieteen erityisasiantuntijat : Kemistit

Descripción de la oferta de trabajo:

Bonalive Biomaterials Oy

As the world seeks answers to the growing threat of antibiotic resistance, Bonalive represents a new standard in patient care. Evolving at the intersection of technology and human biology, our Smart Healing™ technologies reduce antibiotic treatments and enable a better quality of life for patients. Smart Healing™ encompasses our commitment to our customers. It defines everything we do, in providing patients and surgeons well-proven and safe bone regenerative products in orthopedics, trauma, spine, septic bone and ear surgery.

We are looking for a diligent

Regulatory/Quality Assurance Specialist/Manager

Turku, Finland

Your main tasks will be the following:

-Support planning and execution of clinical evaluation and post-market surveillance (PMS) activities

-Analyse and interpret clinical and PMS data

-Prepare clinical evaluation and post-market surveillance (PMS) documentation

-Follow the clinical evaluation and PMS requirements and support in product registrations

-Collaborate with sales, marketing, and R&D teams and work closely with vigilance and risk management

We expect you to have:

-Bachelor degree or M.Sc. (medicine, pharmacy, biosciences or another relevant scientific discipline)

At least 3 years' experience in medicine, pharmacy, biosciences or another relevant scientific discipline

-Experience from clinical evaluation and/or clinical studies (pharma, MD or IVD)

-Understanding of scientific/clinical research methodology

-Demonstrated writing cabability and critique of clinical and regulatory documentation

-Knowledge of MDR (2017/745) preferred; basic knowledge required

-Independent, self-directed person with excellent organization and communication skills

-Good or excellent English writing skills

-Good Finnish communication skills

-Good or excellent MS Office skills

You have excellent attention to detail, and scientific and statistical mindset. You build trust, good working relationships and communicate effectively with your colleagues and across functions.

We offer you a unique small company atmosphere with an ownership mindset that allows you to make close-to-the-customer decisions and an innovative approach in seeing beyond what is possible today in medical device technology. You will work closely with our skilled sales, R&D and QA teams, playing a key role both in maintaining of our products and in commercialization of new solutions to healthcare professionals. Your contribution will make an important impact in the world where infections need to be increasingly treated and prevented with new solutions without antibiotics.

Welcome to our team!

The position will be filled as soon as a suitable applicant is found.

Bonalive is a smart biomaterials company transforming the future of healthcare. With one of the most evidence-based technologies in the industry, we are creating a smarter future for healthcare. Bonalive is an ISO 13485:2016 certified, Class III medical device company, headquartered in Turku, Finland. www.bonalive.com

For further information about the position, call Anne Timonen, Director Quality, tel. +358 40 173 7720, Wed 5.5. 13.00-14.00 or Thu 6.5. 15.30-17.00.

País del trabajo: Finlandia.

Número de puestos: 1.

Empleador: BonAlive Biomaterials Oy.

Instrucciones para solicitar:

If you are interested, please send your application and CV to bonalive.com" rel="nofollow">recruitmentbonalive.com by Tue 11.5.2021. We go through applications as they come, so do not hesitate to send your application today.

Identificador de la vacante:10731216.

Ver las 42 ofertas de trabajo de Profesionales científicos e intelectuales : Profesionales de las ciencias y de la ingeniería : Físicos, químicos y afines : Químicos ofertadas.

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