Regulatory Affairs Manager
Start-up company with strong financial backing who are going to soon be entering a large phase of growth.
- Develop the Regulatory strategy for new products and manage regulatory submissions to regulatory authorities and notified bodies.
- Compile regulatory documentation to support global pre and post market clinical studies.
- Provide regulatory oversight regarding customer complaints.
- Work cross functionally with R&D, Manufacturing and Quality Assurance departments.
- Ensure compliance to US Regulations, ISO 13485, MDD 93/42/EEC, MDR 2017/745 and other jurisdictions as required.
- Provide guidance for company employees regarding regulatory affairs.
- Review and approve product labelling changes, promotional literature and marketing materials prepared by the Company and its distributors.
- Provide input to regulatory aspects of design control, change control, non-conforming process.
- Supervision of regulatory team.
- Bachelors or Masters’ degree with 7 years or more experience in regulatory affairs within medical device, preferable cardiovascular.
- Experience of working with the following standards: ISO 13485; ISO 14155; 21 CFR 820; 21 CFR 814; 21 CFR Parts 50, 54, 56, 812; MDD; EU MDR; ICH GCP.
- Quality management system experience.
- Experience of CAPA, Auditing and Risk Management (including FMECA).
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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