Regulatory Affairs Manager
Regulatory Affairs Manager
My client is a Galway based medical Device manufacture with a new positions for a skilled Regulatory Affairs Manager. This role is commutable from Mayo & Roscommon, located outside of Galway City where they are headquartered. As the Regulatory Affairs Manager you supervise the Regulatory Affairs team to ensure that it runs in an efficient manner.
Areas of Responsibility:
- Managing the day to day workload and operational issues of the regulatory affairs team.
- Setting team and individual objectives, carrying out team performance appraisals, generating staff training plans and tending to performance-related issues.
- Oversee the day to day running of Regulatory Affairs programs in accordance with internal procedures and regulatory requirements.
- Maintains an excellent understanding of the global medical device regulations.
- Seek out and implement ways to improve the Regulatory Affairs Department.
- Ensure compliance to 21 CFR 820, ISO 13485, MDD, MDR, MDSAP, other regulatory requirements, company policies & procedures.
- Provide regulatory leadership to development/cross-functional teams in alignment with issues of possible regulatory ramifications.
- Prepare submissions for medical device design changes and /or manufacturing changes as needed.
- Reviews product and manufacturing changes for compliance with applicable regulations.
- Reviews protocols and reports to support regulatory compliance and submissions.
- Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body)
- Uses project management experience to create timelines and provide deliverables for regulatory projects.
- Provides guidance to management on upcoming regulatory changes and how those changes will impact the company.
- Bachelor’s Degree in relevant technical discipline
- 5-10 years of experience in Regulatory Affairs.
- 5 years of MDR specific experience.
- Some international travel may be required
For further information on this Regulatory Affairs Manager role in Galway, please contact Marchon Monroe on 0860449473 / email@example.com
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