Jobbtitel: Technical and Regulatory Affairs Project Manager

Arbetsbeskrivning:

Neoss, a provider of global dental implant solutions, is seeking a Technical and Regulatory Affairs Project Manager for our facility in Mölnlycke where the corporate functions of Development, Research, Quality and Marketing are located. The head quarter of Neoss is in Harrogate, UK. Please refer to www.neoss.com for further information on Neoss.

The Technical and Regulatory Affairs Project Manager manages selected development projects and regulatory aspects of projects and medical device submissions with Health Authorities on a worldwide basis. The ideal applicant for this position enjoys integrating business objectives, technical information with regulatory requirements. We are looking for an enthusiastic, self-motivated, highly organized and flexible person to join the team on a full time basis. As part of a growing company in an interesting medical device business, there is a good opportunity for personal fulfilment

The key areas of accountability are pre-market activities such as:

- Monitor, control and report the development of Technical projects by following set procedures.

- Reporting and documenting activities needed to fulfil the Essential requirements, i.e. mechanical testing, process validation, risk analyses, design reports.

- Monitor and implement new regulations and change in existing regulations and advice internal process owners in order for Neoss to be compliant with regulations on a worldwide basis.

- Consult with and advice the necessary internal functions in order to achieve CE marking, FDA clearances and approval in other markets such as Asia and the Middle East.

- Be the Regulatory Affairs responsible in projects delivering New product development, Line extensions and upgrades according to product launch plans.

- Be the Regulatory Affairs consultant and coordinator supporting Operations, Development and Quality Assurance in order to build and mentor best practice

- Create, review and approve documents necessary for achieving product approvals and marketing claims.

Experience:

- You must have experience from the Medical Device Sector - preferably with Dental Implants - for at least five years and including 2 years of Regulatory Affairs experience. Preferably you should have a university degree, or equivalent, in Biology, Engineering or a related subject, or a solid product development experience with interest and ambition to focus further on regulatory affairs

- Experience from working in an international environment using English on a daily basis, both orally and written, is a prerequisite, as well as Swedish.

- In order to succeed in this role you must remain up to date with new and changing regulations. You are a good organizer and you do have the ability to establish fruitful relationships and maintain networks, as you will be the link between our internal departments, authorities and external partners.

- You have detailed knowledge about Project leading and Technical Files for medical products including initiating and writing reports related to mechanical testing and validation activities

Timmar per vecka: Tjänsten kräver resande i och utanför Sverige

Arbetsgivare Namn: NEOSS AB

Arbetsgivare adress: MÖLNLYCKE FABRIKER 3 43535 MÖLNLYCKE

Form av kontakt:
Fredrik Engman titel : telefon 1: 031-881280(vxl) telefon 2: 031-883903(direkt) mobil: 0709792892 e-post: fredrik (at) neoss.com

Arbetsgivare telefonnummer: 031-881282

Arbetsgivare faxnummer: 031-881289

Jobb kort beskrivning:
Engineering professionals not elsewhere classified

Land: Sweden

Område: Västra Götalands län

Avtalstid: Permanent

Typ av kontrakt: Full time

Källa till jobberbjudande: Public Employment Service of Sweden(AMS)

Hur man ansöker: Other - see free text