Regulatory Affairs Manager to ImmunoIVD AB
Poolia Sverige AB / Sjukhusteknikerjobb / Stockholm
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hela Sverige ImmunoIVD AB is experiencing exciting growth and is now looking to recruit a driven Regulatory Affairs Manager to join the company. ImmunoIVD's focus is designing and producing innovative molecular assays for the detection of rare immune disorders in children such as severe Combined Immunodeficiency in new-borns (also known as SCID).
In this role, you will have the opportunity to work cross-functionally with both internal and external collaborators and help drive the company's visions and goals by the excellent management of regulatory activities. This means ensuring that our IVD products are in line with regulatory requirements, ensuring new market authorizations and post-market activities.
We are looking for someone with a can-do attitude, problem-solving mind-set who seeks a fun and exciting workplace with dedicated people. If this sounds interesting to you - come join us!
The role is full time and based at ImmunoIVD's headquarters in the beautiful area of Nacka Strand, Sweden. We will evaluate applications continuously and we welcome your application today!
JOB DESCRIPTION
As Regulatory Affairs Manager, you will support the company with your expertise in IVD regulations and be responsible in ensuring that regulatory requirements are fulfilled for the company's IVD product portfolio.
Key duties and responsibilities include:
• Ensure product development is carried out based on QMS and regulatory requirements.
• Develop regulatory strategies and provide subject matter expertise for regulatory compliance according to EU and non-EU directives
• Develop and update the technical documentation and files in support of CE marking, 510(k), or other approval procedures
• Compile documentation that is part of the technical documentation such as risk analysis and performance evaluation plans.
• Perform post market surveillance.
• Understand and investigate other non-EU markets with regards to regulatory demands
QUALIFICATIONS
Key qualifications include:
• A MSc / PhD in a scientific discipline
• >5 years' working experience in the field of Medical Devices or IVD through positions in industry, consultancy or regulatory agencies, in quality or regulatory roles
• Excellent knowledge in IVDD, IVDR, ISO 13485 and ISO 14971
• Experience in sales and marketing within life sciences is preferred.
• Preferably you have been part of product development and CE-IVD certification (class general) of a similar product (IVD kit).
• Preferably you have performed registrations of IVD products in other non-EU markets
• Excellent in English (written and spoken). Other European languages is a strong plus.
We are looking for a structured and analytical team player with a high sense of responsibility, who looks for ways to improve and promote regulatory compliance and thrives in translating regulatory requirements into practical, workable plans. We believe you to be a person with strong dependability, attention to detail and natural ability to prioritize tasks while maintaining a high standard of quality. You enjoy working in a fast-paced environment and in a smaller entrepreneur-driven company and will get the benefits of a greater involvement in company decisions, an understanding of how the company functions, and obvious opportunities to grow with the company.
OUR STORY
ImmunoIVD AB is a Swedish company founded in 2015 that produces neonatal screening kits for severe primary immunodeficiency disorders (PID). Our aim is to continue with the development of new assays to detect other forms of PID. No matter how rare a disease is, we have to strive to detect it as early as possible to increase the chances for all children to grow up and live life to its fullest.
The majority of the company is owned by Mabtech, a well-established and successful biotech company with more than 30 years' experience in developing and producing products for the biomedical market. The scientific advisory board consists of leading and renowned researchers within the field of clinical immunology and immunogenetics.
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2019-10-30ErsättningFast lön
Så ansöker duSista dag att ansöka är 2019-11-30
Klicka på denna länk för att göra din ansökanFöretagPoolia Sverige AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "55070".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Poolia Sverige AB (org.nr 556426-7655),
http://www.poolia.se Arbetsplats Poolia Life Science & Engineering AB
Jobbnummer 4895099
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