I'm working with a medical device company in Galway for the opening of Regulatory Affairs Manager II. The company hold a portfolio of 13,000 products and are at the forefront of the medical device industry. Their presence in Galway extends almost 25 years and continues to be one of the most highly respected medical technology leaders in Ireland.
What I will be doing as Regulatory Affairs Manager ?
- Manage domestic and international regulatory activities and issues occurring at the company, including compiling submissions for US, EU and International approvals for Class III and other devices. Taking responsibility for regulatory activities related to new product manufacturing and market introduction, as well as regulatory issues relating to labelling, releases, and change orders.
- Manage departmental procedure development and implementation.
- Preview device labelling, product and manufacturing changes for compliance and applicable regulations.
- Provide regulatory strategies for new product introduction.
- Manage regulatory activities in maintaining regulatory compliance status of products in commercial distribution.
- Manage interactions and relationships with external regulatory bodies on behalf of the company in relation to product approvals and post market compliance
- Provide updates on regulatory requirement changes, either on individual product specification or quality systems and manage regulatory aspects on implementation of new regulations or requirements
- Interface with divisional regulatory colleagues on regulatory matters relating to new product submissions or management of changes to existing devices.
- Assist in the preparation and the management of regulatory and quality system audits.
- Strong team member with the ability to identify and drive quality and compliance improvements.
- Good administrative / organisational ability with attention to detail is required.
- Excellent communications skills.
- Establish and support a work environment of continuous improvement that supports the companies Quality policy, Quality System & the appropriate regulations for the area.
- Ensure employees are trained to do their work and their training is documented.
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Lead a group or team of employees in the achievement of organisational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization
What I need to be Regulatory Affairs Manager ?
- Degree (HETAC Level 8) qualified, in a relevant field with a minimum of 8 years' work experience in a medical device environment
- People management experience is desirable
- Direct regulatory affairs experience with higher class devices desirable.
Don't miss out on this great opportunity to join a great team and progress your career.
To find out more about Real please visit www.realstaffing.com
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