Snr Quality and Regulatory Specialist, EMEA

40000.00 - 45000.00 GBP Annual + GBP40000 - GBP45000/annum 7-10% bonus plus benefits
13 Jul 2017
10 Aug 2017
Contract Type
Full Time
Position Summary

The individual will be a member of the Regulatory and Quality team, covering the Europe, Middle East and Africa (EMEA) region.
The team also acts as EU Authorised Representative for the non-European, manufacturers.
Primary focus for the Snr Quality & Regulatory Specialist EMEA, is the active involvement in, and development of, Post Market Surveillance process in the EMEA region.
This will be achieved through regular interaction with the corporate Quality and Regulatory functions as well as the EMEA based commercial and service/repair functions.
Working within the Vigilance function of the EU Authorised Representative may also require the direct communication with National Competent Authorities and relevant Notified Body's as well as customer/user interaction as required.
the Snr Quality & Regulatory Specialist is also responsible for the development and maintenance of a company-wide regulatory intelligence system and associated processes.
To incorporate input obtained internally from other functions, as well as directly from appropriate external sources.
The position also holds a key role in the transitioning of the business to compliance with the new EU Medical device Regulation as well as other EU-centric standards and regulatory initiatives.
Additionally, the Snr Quality & Regulatory Specialist will support the EMEA commercial business through supply of accurate Quality and Regulatory information for tenders on request as well as providing direct support for local affiliate Quality Management Systems as required. Major

Responsibilities -

Develop and maintain processes throughout the EMEA region for the collation and analysis of PMS information to feed into the global PMS process.
Support the global Complaint handling teams and EU Authorised Representative in ensuring that EU adverse incident reports and responses to vigilance related enquiries are completed accurately and submitted to Regulatory authorities within specified timelines.
Work with the extended quality and regulatory team in developing effective systems and processes by which information on current and future regulations is compiled, assessed for impact and communicated throughout.
Utilize international medical device laws and regulations and provide regulatory advice regarding EMEA laws and regulations. Providing effective communication to Global Regulatory Affairs Department regarding new regulations, policies and initiatives that could impact KCI's products and processes.
As appropriate and as directed, actively participate in relevant industry association committees and working groups at a local and European level as assigned by management.
Maintain an awareness of current and future regulations, standards and guidance appropriate to products and processes.
Provide Subject Matter Expert support and guidance through the transitioning of the business to compliance with the new EU Medical device Regulation as well as other EU-centric standards and regulatory initiatives.
Provide support and guidance relating to Quality Management Systems within the EMEA commercial/affiliate sites to ensure alignment of QMS documents and processes with global policies and procedures. And to assist the commercial functions in maintaining appropriate certification to appropriate QMS standards (ISO 9001).
Work with the extended quality and regulatory team as well as the EMEA commercial team in developing and maintaining effective systems and processes by which consistent and accurate regulatory and quality information may be provided in support of tenders and similar bidding processes.
Conduct training and coaching of personnel who interact with the EMEA Quality and Regulatory/ EU Authorised representative systems and processes. - Support Regulatory and Quality team in any internal or external audits as directed.
Contribute to the writing, review, and revision of regulatory SOPs/WI's/Policy/etc.
Conform to, support and enforce KCI policies and procedures.
Participate in any and all reasonable work activities as may be deemed suitable and assigned by management.

Position Qualifications Experience

Minimum of 5 years experience in a professional role within Quality Assurance / Regulatory Compliance / Regulatory Affairs in the Medical Device industry.
Recent involvement with National and/or European Medical Device trade association working groups or similar is desirable.
Experienced in supporting the development of systems/processes within a Medical Device Regulatory environment.
Excellent working knowledge of global Medical Device Regulations and relevant International Standards (particularly quality system standards).
Demonstrated ability to motivate and influence cross-functional and multi-national teams and individuals.

Bachelor degree or equivalent in Engineering or Science related field preferred but not essential assuming significant relevant experience. Personal Characteristics
Ability to sympathetically influence the actions of persons in different areas of responsibility and from different cultural backgrounds to perform in line with Regulatory requirements.
Strong self motivator with ability to work unsupervised to achieve pre agreed objectives/targets.
Proficiency with Microsoft office software.
Strong ability to communicate effectively orally, in writing and making use of appropriate media.
Willingness to learn and develop new skills and competences as Regulatory requirements change over time.
Flexible approach to work is essential due to the potential diversity of the position.
Willingness and ability to travel if required ( Ability to maintain confidentiality and discretion in business relationships and exercise sound business judgment.
Fluency in more than one European Language is an advantage but not essential