Regulatory Affairs Specialist
Chasseur de têtes: Life Science Recruitment
Appareils de technique médicale
Cork - Irland
Chef de projet / Expert confirmé
En présentiel
Experteer Overview
As Regulatory Affairs Specialist, you will help ensure compliance for a growing medical device company in Cork. You will drive regulatory submissions, post-market activities, and MDR migration in a hands-on, fast-paced environment. You will partner with QA and cross-functional teams to align product development with CE and FDA requirements, influencing regulatory strategy and risk management. This role offers meaningful impact in shaping regulatory pathways and maintaining a robust QMS in a dynamic startup setting.
Responsabilités
- Support regulatory submissions for CE/FDA and manage significant changes with Notified Bodies
- Collaborate with QA to ensure QMS alignment with regulations and audits
- Lead post-market surveillance activities, including handling complaints and adverse events
- Assist in migration from MDD to MDR within the organization
- Coordinate with suppliers on process validations and risk management for regulatory compliance
- Provide regulatory insight to product development plans and cross-functional teams
- Monitor global regulatory trends and assess impact on business and product development
- Evaluate manufacturing, labeling changes, and promotional materials for regulatory impact
Principales exigences
- Bachelor’s degree in engineering or science
- Minimum 4 years of experience in a medical device company
- Experience with regulatory agencies and submissions (CE, FDA, 510(k))
- Knowledge of ISO 13485 and ISO 14971; familiarity with MDD and MDR
- Strong project management and ability to meet deadlines
- Excellent problem solving and communication skills
- Self-motivated, highly organized, detail-oriented
- Ability to work in a cross-functional, fast-paced environment
Description du poste
As Regulatory Affairs Specialist, you will help ensure compliance for a growing medical device company in Cork. You will drive regulatory su…
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