regulatory affairs specialist in blackpool

posted
job type
contract
salary
£ 65,000 per year
apply now

job details

posted
location
blackpool, north west
job category
manufacturing
job type
contract
working hours
Full-Time
salary
£ 65,000 per year
reference number
RASDSJ
apply now

job description

Are you an experienced Regulatory Affairs Specialist ? Are you looking to take on a new challenge with a leading Medical Devices Manufacturer? If so we are looking for individuals just like you!

We are looking for a Regulatory Affairs Specialist to manage regulatory activities and provide regulatory advice to support business objectives. You will also be responsible for developing and implementing regulatory strategies and plans.

This opportunity is a contract role until the end of 2019, working 37 hours per week Mon-Fri.

Responsibilities:



* Support and coordinate regulatory approval for new products and changes to existing products by ensuring that dossiers are created where appropriate in line with local country requirements (incl. CE mark and US)
* Ensure regulatory projects are standardized to obtain earliest possible registration approval
* Allow clear visibility to risk and early identification of regulatory challenges
* Enable the development and commercialization of new products and support to other business unit projects
* To support functional imperatives for Joint Reconstruction Regulatory Affairs
* Establish and maintain good relationships with, and represent the Regulatory Department to worldwide regulatory colleagues, distributors and external regulatory bodies
* Liaise with internal departments and worldwide company colleagues to provide regulatory direction, input, support and advice
* Establish and maintain processes for maintenance of registrations
* Be aware of progress and developments of worldwide regulatory requirements and address changes as appropriate
* Provide regulatory input for post market surveillance and vigilance activities, audits, non-conformance disposition, corrective and preventative actions, post market product changes and product literature approval
* Follow the quality standards and regulatory requirements
* Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times
* Resolving complex issues as they arise

Experience/Qualifications Required:



* Bachelor's (minimum 3 years' experience) or Master's (minimum 2 year of experience) Degree in engineering or life sciences is required; or Advanced Degree (PhD with 1-2 years of experience) is preferred
* 2-3 years of experience in European Medical device industry especially with regulatory, quality or engineering
* Strong knowledge of: ISO 13485 and ISO 9001, QSR
* Understanding of MDR/MDD requirements
* MEDDEV guidance documents applicable to Medical Devices products and processes
* Reasonable knowledge of: FDA requirements, registration requirements in further global markets would be an asset
* Strong understanding of Risk Management process, label and labelling, change management is desired
* International experience preferred
* Proven exceptional written and oral communication skills
* Strong knowledge and skills in MS Office
* Familiarity with Technical Documentation structure according to STED required
* Strong interpersonal and diplomatic skills
* Team work oriented, within a multi-functional and multi-national team
* Customer / service orientation
* High analytical, planning and organisational skills; able to set priorities

If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.