Company: Thornshaw Recruitment
Closing Date: 24 Nov 16
Salary (£): Negotiable
Global medical device company has a number of vacancies for Regulatory Affairs Specialists!
These are permanent positions and responsibilities will include the following:
• Maintain an excellent understanding of global medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required.
• Ensures a thorough understanding of the products they are assigned.
• Communicates country/region specific regulatory requirements to the regulatory specialists/ managers.
• Develop global regulatory strategies for Company medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
• Advise other Company 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.
• Ensures the biocompatibility requirements of the product are adequately addressed
• Communication of the clinical requirements for regulatory registrations for the product and working as part of a cross functional team to ensure that they are adequately addressed.
• Communicates directly with notified bodies and other regulatory authorities to ensure product approvals are achieved in a timely manner.
• Third level Qualification in Science/Engineering, at least 3 years experience in a regulated industry in a similar role.
• Knowledge of requirements in GHTF countries including regulatory requirements in accordance with ISO13485, MDD 93/42/EEC and FDA QSP 21CFR Part 820 as required.
• Knowledge of requirements in other jurisdictions where required.
• 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.
• Willingness to travel on company business
For a full Job Spec and to apply for this role please call Deirdre on +353 1 2784671 or e-mail your CV to firstname.lastname@example.org
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
Barton House 6 Old Dublin Road Stillorgan Co. Dublin
|Tel:||00 353 (1) 278 4671|
|Fax:||00 353 (1) 278 4672|
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