Regulatory Affairs Specialist
I am currently working with the world's leading medical device company specialising in the design, manufacture and commercialisation of aerosol drug delivery systems,founded in Galway in 1997 and has been growing ever since. They currently have an opening for an experienced Regulatory Affairs Specialist to join their team. This is a permanent position with great benefits.
- Bonus 9%
- Pension contribution 4%-8%
- Healthcare for yourself and dependants
What will I be doing as a Regulatory Affairs Specialist?
- In conjunction with Section Leader Regulatory Affairs, define regulatory strategy for individual devices within the Product Development Process.
- As appropriate, manage CE mark Submissions / Significant Changes and Notified Body interactions.
- Assist with the preparation of 510(k) regulatory filings and subsequent FDA correspondence on submissions.
- Manage Regulatory Assessment of any Device / Quality System changes, and any subsequent notifications that are required to be made to Regulatory Agencies.
- Work with the Commercial Team and Distributors, to ensure country specific registration activities are understood and appropriately addressed.
- Participate in Notified Body / Regulatory Agency audit preparation and follow up. In conjunction with the Section Leader Regulatory Affairs and in a timely manner; identify and initiate required action(s) to address any adverse trends or regulatory compliance issues.
- In order to coordinate the variety of regulatory related tasks, the role requires a high degree of flexibility, and structured time and task management.
What I need to be a Regulatory Affairs Specialist?
- A minimum of a Degree (Hons) in Quality/Regulatory or related discipline,
- At least 2 years practical and relevant experience in Regulatory Affairs, medical device preferable.
- Excellent verbal and written communication skills.
- Excellent attention to detail skills.
If you think the position in Galway is the step in the right direction for you and you have experience in a similar role, don't hesitate in applying. If you think you might be interested in becoming a Regulatory Affairs Specialist and are looking for more information, I will contact you upon application and discuss this further with you!
To find out more about Real please visit www.realstaffing.com
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