Regulatory, Medical device specialist

About us:
We are an international human resourse and leadership company. Focusing on helping our clientes to find and follow up the competence they need.

About the job:
Regulatory, Medical device specialist - education and/or longer experiences in the field, with proven record.

You have a good overview over the : The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical device.
Competence in and experiences with ISO13485 - Medical Device
Experiences with using a folder-based QMS system, as well as implementation of Greenlight Guru
Experiences with working with documentation.

Audits to various standards and regulations.

MDSAP Lead Auditor services.
Good also if you have had the role as a : Authorized Representative (or EC-REP)

Skills:
Regulatory, Medical device specialist - education and/or longer experiences in the field
English fluent written and oral, plus with other languages
Flexibel person
Like to work with the rest of the team.
Plus if you have some certifications in the regulatoric medical device field
You like to all the time develop your self
You are a good listener, to listen to the need of the customers and our partners.
You are orginazed person with focus on the details
Work well in an international team

Place of work:
Norway or remote work towards Norwegian clients.

Additional information:
Remote work - then we need to agree about the consultant fee with each and one.