The Senior Manager Regulatory Affairs plans and prepares complex regulatory submission documents for regulatory filings for all medical devices in Europe, Africa and Middle East (EAME); including CE marking and product registrations outside of the EU. Utilizing detailed, in-depth understanding of medical device regulations, provides global project and regulatory teams with timely input and guidance. Supports management with implementation of departmental strategies and policies.
• Provides clear, constructive regulatory advice and guidance to global project and regulatory teams.
• Ensures effective planning, tracking, archiving of activities, especially submissions, internal memos and key correspondence.
• Independently and without supervision, prepares complex regulatory documents for product approval in EAME.
• Maintains Design Dossiers and Technical Files ensuring contents are current and accurate.
• Performs peer review of complex regulatory documents.
• Establishes strong and effective relationships with global regulatory teams thereby ensuring RA activities are in line with global and regional business priorities.
• Has regulatory expertise and knowledge of regulatory requirements and regulations with ability to strategically interpret and communicate requirements.
• A minimum of BS degree or equivalent in a scientific field, plus appropriate experience in regulatory affairs; the length of which is dependent on the level of qualifications achieved.
• Sound Medical Device experience, including a successful track record in the registration and maintenance of products within Europe.
• Sound knowledge of relevant Quality Standards. Direct interaction with competent authorities and Notified Bodies.
• Excellent organisational/ planning and negotiation skills
• Excellent communication skills, both written and verbal (in English).
• Good interpersonal skills and the ability to influence others without formal authority.
• Ability to work effectively and collaboratively across the global organisation and cross-functionally
Full job description and company details are available upon application, apply below. This position is being dealt with by Joseph Dykes at Meet, please call 0203 019 5972. You can also e-mail us directly at Joseph@peoplewithchemistry.com to discuss in confidence.
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