Senior Regulatory Affairs
Job ID: JOB-12709
Senior Regulatory Affairs Specialist- Contract
We are looking to speak with experienced Regulatory Affairs Specialists about this great new job opportunity in Galway with one of our leading clients? This company stands out for their culture, exceptional career development pathways and unrivalled rewards and recognition packages. This exciting new job opportunity in Reg Affairs is located Galway. Galway, voted “Europe most Friendliest City 2020”! Apply to us to find out more about this great job opportunity in Reg Affairs in Galway and we can talk though if it’s the right job for you.
In the Regulatory Affairs department , the mission is to develop innovative strategies for regulatory approval, anticipate and respond to changing regulatory requirements, and provide strategic leadership to influence the global regulatory environment to benefit the patients served. Regulatory Affairs is a key function within the business and this role is supporting the Coronary and Renal Denervation business.
- Directs or performs coordination and preparation of document packages for regulatory submissions.
- Teams with business unit Regulatory Affair Specialists and international regulatory staff to provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to develop robust regulatory strategies and resolve questions from regulatory agencies.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Supports change control activities to support global approval and implementation of product and process changes
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol/evaluation reports for regulatory compliance.
- Keeps abreast of regulatory procedures and changes. Develop internal procedures to ensure continuous compliance with all regulatory requirements.
- May direct interaction with regulatory agencies on defined matters.
- Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed.
- Identifies and develops best practices within the Regulatory Affairs Department including continuous development initiatives
- We are looking for a person qualified to Level 8 Science or Engineering Bachelor’s Degree/Masters with a minimum of 4 years of relevant experience. A Regulatory Affairs qualification is desirable, but not mandatory.
- Regulatory experience in Medical Devices and or Pharmaceuticals is required, and related relevant experience will also be considered.
- You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams
- You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
- You collaborate with others and create alignment with team members.
- May provide guidance, coaching and training to other employees within job area
- You set high standards and drive accountability in the execution of your responsibilities and you model ethical behavior.
- You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.
For further information on this role in Galway please contact Aisling Kidney on 0872197421 or email@example.com
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