Senior Consultants RA/QA and Development, Medical Devices

SRS | Stockholm/Uppsala/Mälardalen

Senior Consultants RA/QA and Development, Medical Devices

Would you like to be part of a growing organization where you get a large degree of influence and work with experienced colleagues? At Scandinavian Regulatory Services AB (SRS), your base would be the office in Danderyd. Customers includes small and medium-sized companies that need the support of senior expertise in a variety of areas , as well as larger companies that need additional support in their organisation. At SRS, you get both the proximity to and the community of your colleagues, while you are responsible for your own projects with our customers. SRS is a Swedish consultancy firm that offers regulatory and quality expertise and services to the pharmaceutical, medical device, cosmetic and associated industries.

SRS is a growing company with senior employees and a large international network with specialized consultants/consultancies in various fields and countries.

Main tasks

Scandinavian Regulatory Services are looking for two experienced medical device/IVD consultants within the areas of regulatory affairs, quality assurance and medical device development. The consultants will have expertise within at least one of the following areas; medical device/IVD/combination products/medical device software. 

Responsibilities

Management of assignments within the area of expertise, such as:

  • Regulatory and Quality Assurance related activities
  • Creating and/or maintaining Quality Management Systems
  • Creating and maintaining technical files/product registration files
  • MDR compliance
  • EC and ISO-certification (product and quality system)
  • FDA registration
  • Audits as well as inspection support
  • Development related activities for medical devices/IVDs/combination products
  • Project management
  • Regulatory aspects throughout development
  • Risk management
  • Human factors engineering/usability
  • Biocompatibility
  • Post-Market surveillance related activities
  • Act as PRRC

Experience

  • Previous experience from working with RA/QA within medical device area (device/IVD/combination products/medical device software (Europe and US))
  • Experience from development of medical devices/IVD
  • Auditing experience
  • Experience in communication with notified bodies/FDA
  • Experience in communication with authorities
  • Experience of combination products is a merit
  • Professional level of English (spoken and written) is a requirement
  • For work with combination products, knowledge of pharmaceutical RA/QA is qualifying

Location

Preferably in Stockholm/Uppsala/Mälardalen, but there is flexibility for work on a distance. However, regular meetings will be held at the office in Danderyd/Stockholm.

Corporate culture and conditions

Personal sustainability and balance in life are important to the company. Part-time work can therefore be discussed if desired.

About SRS

With the Scandinavian Regulatory Services team of experts and through our network of selected partners we specialize in providing expert support for market access through quality management and regulatory affairs, as well as compliance activities in the post-approval phase.

Founded 1992, SRS offers expert and experienced consultants servicing regulatory affairs, quality assurance, product development, in the areas of medical devices, IVD, pharmaceuticals, drug-device combinations, cosmetics, and food supplements. We provide guidance through the classification, product development, regulatory approvals and quality management steps for medical device/IVD and pharmaceutical market, including strategic advice, due diligence, project management and the preparation of documentation for submission. Further we help cosmetic manufacturers, importers, and distributors to meet the requirements of the cosmetics regulation. We can support you on quality solutions and labelling advice for your food supplements as well as registration of FSMP (Food for Special Medical Purpose).

SRS has all the expertise in-house to support a company in the process to establish the necessary documentation for drug-device combination approval. We work with companies all over the world to obtain and maintain market access for their products. For more information about the company, please see www.srs.se

How to apply

If this sounds interesting to you, contact one of us below for more information or just submit your application.

We look forward to your application!

H&P Search & Interim:

Torbjörn Ströberg                                                               Catharina Bergold                                

Partner                                                                                  Recruitment & Staffing Manager

Torbjorn.Stroberg@hpsearch.se                                     Catharina.Bergold@hpsearch.se

+46 (0) 703 778 774                                                          +46 (0) 702 179 879