Senior Regulatory Affairs Specialist
Location: Hybrid working opportunity - remote working with partial onsite duties with the company in Galway.
Primary responsibilities are to ensure regulatory compliance for assigned product lines as the Company evolves.
- 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
- 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)
- 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 Bachelors’ 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
- Self-motivated, self-directing, strong attention to detail and excellent time management skills
- Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others
- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
To apply for this position please contact Keeva O’Shea at Sigmar Recruitment T: +353 91 749264 E: email@example.com
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