REGULATORY AFFAIRS SENIOR CONSULTANT FOR MEDICAL DEVICES AREA - Italy
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- The resource shall support compliance projects and also bring new expertise in regulatory affairs for Medical Device area.
- He/She will contributes to improve our Medical Device Regulatory Affairs team, in order to support our client
- Oversee the process of preparing product submissions to domestic and international regulatory bodies and manage the process from inception to approval;
- Interact with FDA, including preparation of PMA/IDE/510K submissions;
- Manage relationship with international Competent Authorities and Regulatory Agencies;
- Plan, review, approve required documents from various departments for filing of required information to Competent Authorities;
- Collaborate with EU and extra EU regulatory to develop global approval strategies;
- Provide regulatory advice and guidance to project teams to ensure submissions meet regulatory requirements;
- Maintain up-to-date knowledge of regulatory requirements;
- Perform audits in Medical Device area;
- This position is an excellent opportunity for a motivated individual to contribute to the growth of an immerging life science consulting firm.
- You will be rewarded for strong performance and provided opportunities to grow professionally.
- Fluent English;
- Willingness to travel;
- Bachelor’s Degree in a life science discipline;
- 3+ years experience in Regulatory Affairs or Quality Assurance in Medical Device Industry;
- Knowledge of Medical Device requirements (ISO 13485, MDD 93/42, 21 CFR part 820, …);
- Knowledge of EU and Extra EU Medical Device Registration Processes;
- 510K and PMA Process;
- Post Market Surveillance;
- V&V Requirements;
- Relocation near one of our offices