Regulatory Affairs Service Representative

Mölnlycke Health Care is a world leading manufacturer of single-use surgical and wound care solutions for the professional health care sector.The Surgical Division offers peace of mind in the operating room by providing a range of outstanding products such as drapes, packs and staff clothing, customised procedure trays, surgical powder free gloves and skin antiseptics, along with various service solutions.The Wound Care Division offers gentle and effective wound healing with a range of unique products based on a patented soft silicone technology, Safetac®.In addition, the assortment includes products for hard-to-heal wounds as well as for compression, dermatology, orthopedics and conventional wound care. On behalf of Mölnlycke Health Care we are now looking to recruit a Regulatory Affairs Service Representative -Surgical The Regulatory Affairs team is looking to recruit a Service Representative - Surgical.The position will be based at the Headquarter in Gothenburg, Sweden and report to the EU General Manager Regulatory Affairs. Position Description Assume a leadership role in the regulatory development, implementation, evaluation, and maintenance of a comprehensive product portfolio that complies with, EU regulations, Corporate Regulatory Compliance and other applicable regulatory bodies or standards. This includes the following key result areas; Responsible for issuing Certificate of Conformity for approved technical files.Responsible for the review and approval of any product claims and verifies there is appropriate documentation in support of claims.Approves product classification (EU).Accountable for information to the Notified body.Approves any product concessions.Directly and frequently communicates and interacts with all departments including manufacturing facilities, R&D and sales/marketing with regards to regulatory and compliance issues. Liaise with Medical-vigilance associate regarding customer complaints and adverse events. Ensuring that the company's products comply with the regulations.Keeping up to date with international legislation and guidelines.Advising scientists and manufacturers on regulatory requirements.Project managing teams of colleagues involved with the development of new products.Reviewing company practices and providing advice on changes to systems. Qualification Requirements Minimum of 3 years experience with medical device regulatory affairs with strong knowledge base in EU, EEC regulations. Experience with Class I, II and III devices Excellent communication skills - both written and oral English and Swedish. Education or Formal Training Bachelors Degree in science/engineering or other appropriate curriculum.3 years extensive and applicable experience in regulatory affairs in regulated medical device products or equivalent Company. Application In this recruitment Mölnlycke Health Care is working with Hudson Global Resources. Please note: When you send your application, in regards to the above advertisement, your information will be registered in Hudson's database.To be registered in Hudson's database means that we might contact you in the future, regarding an assignment that might be of interest for you.All information concerning you will, of course, be handled confidentially and in accordance with PuL (Th