My client has an exciting opportunity for a Quality & Regulatory Affairs Associate to join the team in Dublin, although they will work across Ireland, Asia and the US. They are preferably looking for previous experience with the FDA and Recalls
• 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, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Compile and maintain regulatory documentation databases or systems.
• Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
• 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.
• 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.
• Must have a flexible approach to work and be capable of handling multiple priorities in a fast paced environment.
• Strong attention to detail with a high degree of accuracy and excellent organizational and communication skills.
• Project Management, Organization, Negotiation and Communication skills, and the ability to learn from the experience of others, both inside and outside of the organization
• A passion for continually improving processes with a focus on results.
• Demonstrated people management skills, a strong team builder with good strategic perspective who possesses strong influencing skills.
Full job description and company details are available upon application, apply below. This position is being dealt with by Joseph Dykes at Meet, please call 0203 178 7488. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.
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