Senior Regulatory Affairs Specialist
My client are a medical device organisation and are seeking to take on a Senior Regulatory Affairs Specialist. They're located in the heart of Galway, where their centre of excellence is. They have a reputation for introducing and marketing innovative, high-quality products designed to enhance the practice of interventional medicine. They've been in Galway over 20 years and have employ 800 people here, and you could be the next to join them.
This position is responsible for coordinating, preparing, and maintaining regulatory submissions on a global level including European CE-marking and US FDA submissions. Primary responsibilities are to ensure regulatory compliance for assigned product lines as the company evolves.
- Determines global regulatory pathways for various projects for EU, US and International product launches / product enhancements. Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.
- Prepares regulatory submissions to regulatory authorities and/or distributors (including the FDA, Notified Bodies, Health Canada and other regulatory authorities).
- Interacts directly with international regulatory agencies on products / projects at reviewer level. Interacts with various levels of management, external agencies and companies. Works with engineers and technical experts to resolve potential regulatory issues and questions from Regulatory Agencies.
- Provides support for commercialized products as necessary by reviewing labelling, promotional materials, and product and documentation changes per policy and procedure.
- Maintains and enhances cross-functional team relationships. Provides technical guidance and regulatory training / mentoring to other Regulatory Affairs employees and cross-functional teams. Maintains expertise in worldwide regulatory requirements; establishes and maintains positive relationships with regulators.
- Participates in and assists with FDA facility inspections, Notified Body Audits, MDSAP and other governmental inspections as directed.
- Performs other related duties and tasks, as required
Summary Of Minimum Qualifications
- Education and experience equivalent to a Bachelor's Degree in a technical field such as the biological, physical, engineering or material science disciplines and six years of related industry experience.
- Demonstrated knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), the Medical Device Regulation (2017/745, as amended), and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485 and MDSAP.
- Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
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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