HemoCue® AB develops, produces, and markets medical diagnostic products for Point of Care testing. The fundamental concept behind the HemoCue products is to perform important common blood and urine tests that offer lab quality results at the Point of Care without sacrificing the accuracy and precision offered by a central clinical lab. Tests that are fast and easy to perform - by anyone.

HemoCue HQ is located in Ängelholm, Sweden with about 350 employees. All research & development, manufacturing, regulatory, and quality functions are located in Ängelholm.
Today HemoCue products are being used in more than 130 countries. HemoCue is owned by Quest Diagnostics (http://www.questdiagnostics.com) a leading provider of diagnostic testing, information and services. Further information about HemoCue can be found on
http://www.hemocue.com.

The Quality and Regulatory Management (QRM) department at HemoCue is responsible for continuously maintaining, monitoring and improving the Quality Management System and for ensuring the organisation's compliance with other applicable national laws, regulations and standards. Furthermore QRM is responsible for the implementation of an Environmental Management system for HemoCue. The department has 19 employees today.
Regulatory Affairs Expert TILLSATT
The position

As Regulatory Affairs Expert at HemoCue you will be responsible for maintenance of internal regulatory processes. You will take an active part in Project teams, contributing with regulatory expertise in strategic discussions and product devlopment planning. You will, together with the team, set requirements on products in order to comply with regulations. You will also be leading teams in compilation and preparation of materials for submissions to regulatory authorities. You must be comfortable in having interactions and discussions with regulatory bodies in different countries.

We are looking for a person with several years experience from regulatory affairs, preferably from the medical device industry. You should be structured with an analytical ability and with excellent communication skills.

Main tasks

Product Registration
Maintenance of the Product registration procedure
Maintenance of the procedure for handling of the Technical File
Control the list of Regulatory Standards and Guidelines applicable for HemoCue
Support the rest of the organistion with questions related to Regulatory issues
Provide regulatory input in strategic discussions with the Project teams as part of the product development planning in order to obtain timely regulatory approvals
Coordination of Product registrations on request and maintenance of existing product registrations (including Technical File)
Negotiate and communicate effectively with regulatory authorities to obtain timely product approvals
Report status of Product registration to CAPA (Corrective And Preventive Action) and Management Review

Labelling
Maintenance of the Labelling procedure
Support and review of the Labelling material

Other
Participate as company representative in international standardization groups

Responsibilities

Ensure that procedures and activities related to Product registration, Labelling and Handling of Technical File are in compliance with requirements in ISO 13485:2003 and QSR as well as with applicable regulations and industry best practice
Ensure that non-compliance to applicable standards is reported to Regulatory Affairs Manager
Ensure that deviations from planned activities are reported to Regulatory Affairs Manager

Authorised to

Authorised to act as trainer for the HemoCue organisation regarding requirements on Labelling, Technical File and Product registrations
Authorised to perform reviews of Labelling
Authorised to sign off Product registrations worldwide

Requirements

University degree in science or technology
A minimum of 5 years of experience of HemoCue products or other medical devices and / or similar tasks
Proven good knowledge of regulations for IVD products, standards for quality management systems (ISO 13485 and QSR) and risk management for medical devices (ISO 14971)
Excellent communication skills (verbal as well as in writing) in both English and Swedish
Experience of using Microsoft Office

Required skills and personal characteristics

Strong leadership skills
Highly organized with a strong eye for details
Ability to prioritise and work under pressure in order to meet strict deadlines
Possess a strong sense of responsibility
Builds effective networks of contacts inside and outside the organisation
Gains clear agreement and commitment from others by convincing and negotiating
Makes rational judgements from the available information and analysis
Ability to interpret and present scientific and medical information
Flexible, adaptable and pro-active
Team player

Opportunities with the role

The expertise and commitment that characterize the HemoCue® brand can be found within each individual who works there. HemoCue® personnel are responsible and passionate about helping each other and their customers, whether it’s a question of developing new point-of-care testing systems or solving a problem for a user. HemoCue recognize and commend individual initiative and achievement. At HemoCue® all take part in delivering on their promises.

Contact

For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Recruitment consultants at PeakSearch.
catharina.herbertsson@peaksearch.se, +46 (0)706 152772
eva.runnerstrom@peaksearch.se, +46 (0)701 725379
http://www.peaksearch.se

Application: Apply for the position at http://www.peaksearch.se.