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Job Details

Quality & Regulatory Affairs Associate.

Company: Thornshaw Recruitment
Location:
Reference: TD9326
Closing Date: 22 Mar 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

My client, a global company with offices in Dublin now have a new vacancy for a Quality & Regulatory Affairs Associate.

Requirements:

My client, a global company with offices in Dublin now have a new vacancy for a Quality & Regulatory Affairs Associate.

1.    Principle Responsibilities:
•    Coordinate, prepare, or review regulatory submissions for domestic or international OMGS projects.
•    Ensure all OMGS facilities are properly registered with appropriate regulatory authorities.
•    Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance for OMGS.
•    Interpret regulatory rules or rule changes and ensure that they are communicated through OMGS policies and procedures.
•    Work with other regulatory managers to:
o    Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
o    Obtain and distribute updated information regarding US and international laws, guidelines, or standards.
•    Review product promotional materials, labelling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
•    Recommend changes to O&M Private Brand procedures in response to changes in regulations or standards.
•    Advise project teams on subjects such as regulatory requirements, export and labelling requirements, or compliance issues and proposed device changes or labelling changes.
•    Compile and maintain regulatory documentation databases or systems.
•    Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
•    Develop and conduct employee regulatory training.
•    Review adverse product complaints and file all related reports in accordance with regulatory agency guidelines and coordinate recall or market withdrawal activities as necessary.
•    Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
•    Co-ordinate inspections and audits and provide follow-up information as requested.
•    Direct the collection and preparation of samples for testing as requested by regulatory agencies.
•    To perform all other work as and when assigned.

2.    Education / Experience

•    Educated to degree or equivalent in a Quality or Scientific discipline.
•    Minimum 5 years’ experience working in a regulated environment
•    Experience in supervising or managing a team.

 

For more details on this exciting opportunity please contact Tina at + 353 1 2784671 or email tdunne@thornshaw.com 

For a list of all our current vacancies log on to www.thornshaw.com 

Apply for this job: Quality & Regulatory Affairs Associate.

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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