RA Manager

Hobson Prior currently have an exciting new opportunity for a RA Manager to join one of the world's leading specialised medical diagnostic companies.

Job Responsibilities:

• Lead, manage and organise a team of regulatory affairs professionals for invitro diagnostics manufacturer for global markets including EU, USA, Asia Pac, LATAM including hiring, performance management, budget and headcount.
• Support key development projects to meet strategic business objectives.
• Represent the company for 3rd party submissions for FDA, Notified Bodies and global regulatory authorities.
• Manage global submissions including EU, FDA.
• Represent RA in product development projects.
• Support Internal audits.
• Represent RA in 3rd party audits - MDSAP, FDA.
• Support department in maintaining company compliance to QMS requirements - MDSAP.
• Personnel activities for the team including hiring, performance management, team development.
• Planning activities to support budget and headcount.

Key Skills:

• Strong communication skills.
• Multi-department and multi-level interactions.
• Excellent Written, verbal and presentation skills.
• Ability to communicate internally and externally for department in a professional, ethical and competent manner.

Requirements:

• B.Sc. in Life sciences.
• You will have 5 -10 years in management or supervisory QA/RA roles in healthcare industry (pharma, medical devices or diagnostics).
• You will have 5 -10 years managing or supervising in cGMP or regulated environment compliant with ISO13485, 21 CFR part 820 or equivalent.
• Experience of leading and supervising teams in a regulated industry.
• Scientific knowledge and experience or working with healthcare products.
• Regulatory Affairs and / or Quality assurance background.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.