Quality Engineer/Manager

Quality Engineer/Manager

About the job

Here is an opportunity to join a company with great products and probably the best location in Lund. On the 19th floor with an awesome view you will work with quality assurance, regulatory affairs, pre- and post- markets compliance activities on a daily basis.

The team members of Exini are driven by the vision and passion to help improve the lives of prostate cancer, pheochromocytoma and paraganglioma patients and their families. You will get to work on exciting stuff and work together with our team of highly qualified professionals who love what they do - making lives better!

About the company

EXINI Diagnostics AB, (wholly-owned by Progenics Pharmaceuticals, Inc., New York), is focused on developing sophisticated software (artificial intelligence) that assists physicians and patients in visualizing, understanding, targeting, and treating cancer.

More about the job

We are a global organization with offices in the U.S. (New York City) and Sweden (Lund). You will be positioned in Lund but also work with colleges in NYC. English is your working language even if Swedish is mandatory for your daily work in the office in Lund.

Responsibilities
  • Lead regulatory affairs projects to facilitate the launch of new products in the U.S. and internationally (European Union).
  • Work with colleagues/team as well as third-party regulatory advisor to create and submit 510(k), original IDE, original PMA, EU Design Dossiers and technical files, and other registration documents globally.
  • Provide guidance to team members and develop strategies for product submissions.
  • Planning, overseeing and participating in Risk Management Activities
  • Partner with third-party regulatory advisor to respond to inquiries from regulatory agencies, including the FDA, EU notified body (TUV SUD), and other national and regional health authorities.
  • Develop, maintain, and/or enhance regulatory procedures and processes to ensure regulatory compliance.
  • Monitor the regulatory environment and remain abreast of changes in regulations throughout all major international geographies.
  • Maintain regulatory documentation and update accordingly for license / registration renewals.
  • Manage regulatory inspections and external relationships with regulatory agencies, third-party advisor, etc.
  • Understand and provide input for compliance to various global regulatory requirements, such as ISO 13485, ISO 14971, IEC 62304 and Medical Device Directive (Medical Device Regulation)
Typically work tasks for the QA/RA Manager can be:
  • Control and maintenance of the Quality Management System (QMS) including implementation of new/changed regulations, standards and guidelines
  • Maintaining technical documentation for software as a medical device products according to applicable regulations, standards and guidelines
  • Preparing and filing premarket submission in the EU and US markets (CE marking, 510(k))
  • Preparing and participating in internal as well as external quality audits
  • Planning, overseeing and participating in Risk Management Activities
  • Promote awareness of applicable regulatory requirements and quality management system requirements to top management and throughout the organization
  • Work on product releases and product registrations
  • Overseeing the handling of complaints, non-conformances and communicating with the regulatory bodies in compliance issues
Your profile

To be successful in this role we think you have university degree in Quality, Engineering or similar. Regulatory experience from medical is a big plus, ideally IDE, PMA and or FDA510(k). You must be able to discuss, understand regulatory strategy for emerging product offerings.
Key competences:
  • Getting Results and Communication
  • Teamwork and Collaboration
  • Planning and Organizing
  • Strategic Thinking
Application

Please submit your application by registering your CV and your application on www.dreamwork.se as soon as possible since the search- and selection process is ongoing.
If you like further information, please contact Jonas Leijon, phone: +46 40 660 12 09

About Dreamwork

We are People Management consultants. Instead of having a traditional recruitment and staffing agenda we work harder to match our candidates with our customers' company culture. We have a close relationship with LinkedIn and our recruiters and researchers have certifications in the LinkedIn recruiter modul. Two times, we have been appointed as a Gasell company by Dagens Industri and have the same amount of times been nominated for EY:s "Entrepreneur of the Year". Dreamwork was founded in 2006 and we have delivered staff related services at over 130 cities in Sweden, from Kiruna in the north to Ystad in the south. We are ISO-certified according to ISO 9001.
Mer info
Kontaktperson Jonas Leijon
Telefon 040-6601209
Område Lund
Yrkesroll Industri & Anläggning, Quality Assurance
Typ av anställning Heltid, Tillsvidareanställd
Rekrytering hanteras av Dreamwork
Sista ansökningsdag 14 feb 2020 (26 dagar kvar)