Regulatory Affairs & Communications Specialist

Requisition ID
2017-3030
Job Location(s)
Limerick Ireland
Languages Required
English, Russian
Travel
Less than 10%
Company
Cook Ireland
Position Type
Full Time
Category
Regulatory Affairs
Education
Bachelor's Degree

Overview

 

The Regulatory Affairs Specialist with Russian helps develop regulatory strategies, performs activities associated with obtaining and maintaining regulatory approval to commercialise medical devices in selected target markets, serves as a communication liaison between the Cook Manufacturer and the Cook local affiliates or regulatory authorities.

 

Reporting to: Regulatory Affairs Manager 

 

Find out more about Cook Medical here

Responsibilities

• Responsibility for structuring and managing technical files.
• 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 as required.
• Responsibility for product registration in Russia, Europe and other markets as appropriate.
• Responsibility for ensuring that device labelling is correct and that they meet regulatory requirements.
• Ensures the clinical requirements of the product are adequately addressed as per CERs.
• Serves as a liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor.
• Communicates country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assists with the regulatory strategies.
• Plans and prepares regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/regions.
• 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.
• Responsibility for handling regulatory affairs related queries.
• Communicates directly with the regulatory authorities to ensure product approvals are achieved in a timely manner.
• Performs translation activities as needed.
• Develop global regulatory strategies for Cook medical devices in collaboration with other regulatory affairs or clinical personal (as applicable), especially on high risk devices.
• Advise other Cook functional units (engineering, marketing, operations, quality etc) of the requirements in each target market.
• Coordinates multiple projects at one time and provides regular reports to regulatory management and others as required.
• Provides support to currently marketed products as necessary including input on change requests, etc.
• Maintains and organises appropriate regulatory records to demonstrate compliance with applicable regulations.
• Performs additional duties as assigned.
• Ensure that Cook’s Code of Conduct is considered in all business matters carried out on Cook’s behalf.

 

Qualifications


• Third level Qualification preferably in life Science/Quality;, at least 5 years experience in a regulated industry in a similar role is preferable.
• Fluency in verbal and written Russian.
• Thorough knowledge of the EU, Russian requirements.
• 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 and availability to travel on company business.

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