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Requirements we are looking for

• Advanced English (reading, writing and speaking)
• Bachelor’s / graduate degree in Life Sciences (Bioengineering, Genetic Engineering / Biomedical etc.) or Chemical Engineering, degrees from reputable universities
• Resilient to develop a career in the medical device sector,
• Strong time management skills with the ability to manage multiple competing priorities
• Really ambitious to learn, conduct research and follow-ups
• Goal oriented, flexible, good team-player with an energetic positive attitude
• Able to handle stressful and fast-paced tasks
• Did we mention Good command of English? Yes, indeed we are serious about it :)
   

Nice to Have – (Preferred Qualifications):

• EN ISO 13485:2016 Quality Management System Experience
• Medical Device Design File preparation experience
• Medical Device Technical File preparation experience
• Process validation participation
• Knowledge of Design Controls
• Any test results such as IELTS or TOEFL  

At the end of an extensive training period, The Junior Quality Specialist candidate is going to be evaluated for the below abilities     

• to help the clients in determining methods, techniques, and evaluation criteria for medical devices.
• to assist ISO, EN, MDR, and QSR requirements.
• to support AdviQual Senior Consultants to implement, support, and sustain elements of Medical Device Quality System through procedure generation, training, auditing, and technical support.
• to support AdviQual Senior Consultants for the new product development projects at client times, in terms of Quality Engineering View.
• to work with a team to develop methods and procedures in order to ensure that the appropriate tests are conducted to assure that products meet the required specifications/standards and that the safety and reliability of products are established.
• to support AdviQual Senior Consultants in product requirements, risk management, clinical evaluation report, post market clinical follow up report, test methods, usability and statistical analysis.
   

What we offer is an opportunity in

• Getting exposure from AdviQual Senior Consultants
• Participating in technical trainings, audits
• Acquiring knowledge of medical device Quality & Regulatory affairs (ISO 13485, MDSAP, MDR, IVDR)
• Gathering knowledge of wide range of medical devices production processes and regulatory standards
• Gaining experience on the job, by involving multiple on-going customer projects.
• Learning online tools and collaboration applications.
• Dealing with customers and fast-changing consulting projects
• Delivering punctual tasks under stress.

According to the 3-month performance of the candidate, a long-term contract is going to be signed as a Junior Quality Specialist.

If you have a life sciences background and a way with words, this job fits for you… 

We are seeking junior and senior medical writers to support the development and creation of Clinical, Scientific, and Regulatory documents (such as CEP, CER, PEP, PER, PMCF, SSCP etc.) in accordance with MDR EU 2017/745,  IVDR EU 2017/746 and related guidance documents

This includes

• conducting literature reviews,
• assisting and writing Clinical Evaluation Reports (CER),
• analysis of product complaints and trends,
• collecting and analyzing feedback from various sources to support the CER, PMCFs., Clinical Protocols

 Required Skills 

• Advanced English (reading, writing and speaking) 
• Strong time management skills with the ability to manage multiple competing priorities 
• Bachelor’s / graduate degree in Bio Engineering, Genetic Engineering or other Life Sciences degrees from reputable universities, hoping for a career in the medical device industry and clinical affairs sector 
• Really ambitious to learn, conduct research and follow-up 
• Goal oriented, highly flexible, dynamic, self-confident, good team player 
• Able to handle stressful and fast-paced tasks
• Interpersonal and communications skills,
• Energetic, positive attitude across hard tasks,
• Did we mention GOOD command of English? Yes, indeed we are serious about it since every research and composing report is going to be in Scientific English.

Preferred Skills 

• High level of Bio-Statistic Analysis experience
• Master or PhD degree in related fields,

Desired Skills 

• Good knowledge of ICH-GCP and quality activities in clinical studies
• Experience in clinical studies
• GMP knowledge
• Standard quality management system experience (ISO) 

Desia Clinical & AdviQual is providing professional solutions in clinical, regulatory and quality affairs to medical and diagnostic device companies.

Please follow the links to reach company details.

QUALIFICATIONS AND JOB DESCRIPTION

If you have a life sciences background and a way with words, this job fits for you… 

Desia/AdviQual is providing regulatory and quality solutions to medical device companies.

We are seeking junior and senior medical writers to support the development and creation of Clinical, Scientific, and Regulatory documents in accordance with procedures and European Medical Device Regulation. This includes conducting literature reviews, assisting and writing Clinical Evaluation Reports, analysis of product complaints and trends, collecting and analyzing feedback from various sources to support the CER and PMCFs. 

 Requirements we are looking for 

• Advanced English (reading, writing and speaking) 
• Strong time management skills with the ability to manage multiple competing priorities 
• Bachelor’s / graduate degree in Bioengineering, Genetic Engineering or similar Engineering / Life Sciences degrees from reputable universities, hoping for a career in the medical device industry and clinical affairs sector 
• Really ambitious to learn, conduct research and follow-up 
• Goal oriented, highly flexible, dynamic, self-confident, good team player 
• Able to handle stressful and fast-paced tasks • Exceptional interpersonal and communications skills, energetic positive attitude 
• Did we mention Good command of English? Yes, indeed we are serious about it :)