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Regulatory Affairs Specialist

This job is no longer available

Recruiter
Real Staffing
Posted
22 February 2013
Closes
22 March 2013
Ref
RE-12450145
Contact
Laura Watson
Location
Republic of Ireland
Sector
Contract Type
Hours
Salary
£22048.90 - £33072.92 per annum + benefits

Further information

Primary Function:
The regulatory affairs specialist helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets. The regulatory affairs specialist serves as a communication liaison between the manufacturer and the local affiliates or regulatory authorities.

Responsibilities:
* Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned.
* Advise other functional units (engineering, marketing, operations, quality etc) of the requirements in each target market.
* Ensure the outputs from the individual functional units meet the applicable regulatory requirements.
* Plans and prepares regulatory submissions for specific target markets for new products, product changes and re-registrations as required.
* Maintains registration information (license numbers, expiration dates etc) and obtains re-registration approvals in advance of license expirations to ensure no disruption in product availability.
* Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned.
* Develop global regulatory strategies for all medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
* Communicates directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.
* Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
* Serves as a liaison on regulatory issues between the company's manufacturer and the international local office and/or the company's distribution partner.
* Provides support to currently marketed products as necessary including input on change requests, etc.
* Communicates country/region specific regulatory requirements to the regulatory specialists/ managers.
* Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
* Provides regulatory support to functional units such as the SSC, tenders, customer quality and distribution.
* Performs additional duties as assigned.
* Ensure that the company's Code of Conduct is considered in all business matters carried out on the company's behalf.

Qualifications/Requirements
* Third level Qualification in Science/Engineering, at least 5 years experience in a regulated industry in a similar role.
* Thorough knowledge of the EU, MDD requirements.
* Knowledge of requirements in GHTF countries.
* Desirable to have knowledge of requirements in other jurisdictions.
* Knowledge of medical device quality standards/practises or similar regulated industry
* Good communication and inter-personal skills.
* Proven problem-solving skills.
* Good computer skills including knowledge of Microsoft® Office.
* Proven organisational skills.
* High self-motivation.
* Approved External Auditor.
* Willingness to travel on company business

An excellent salary plus a very attractive benefits package is on offer. This is an urgent requirement so interviews will be immediate. If you are interested in this great opportunity please contact me Laura Watson on 01-8883477 and click apply with an updated CV for immediate consideration.To find out more about Real please visit www.realstaffing.com

To find out more about Real please visit www.realstaffing.com

Real Staffing

Real is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services.