Regulatory Affairs Specialist

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If you are looking to contribute your regulatory expertise to the advancement of medical devices in ophthalmology and thrive in an international and collaborative environment, we invite you to apply.

My client wants you to ensure the adherence of their products to regulatory standards and facilitate their availability in the global market.

About the Role

Join our team as a Regulatory Affairs Specialist focused on non-active medical devices within the field of ophthalmology. In this role, you will play a crucial part in registration projects, ensuring compliance with relevant regulations for approval. Collaborating closely with stakeholders and the team, you will analyse requirements, assess implementation options, and contribute to successful registration projects. Your role will involve managing and overseeing smaller registration projects, participating in international initiatives, and working with an international team of Regulatory Affairs Managers dedicated to ensuring the market availability of my client's products.

Responsibilities

• Registration Projects: Support the registration of non-active medical devices in the ophthalmology field.
• Regulatory Analysis: Analyse relevant regulatory requirements for approval and assess implementation possibilities, working closely with stakeholders and the team.
• Project Management: Plan, manage, and oversee smaller registration projects, ensuring the execution of concepts and planned actions, ultimately leading to successful approval.
• International Collaboration: Participate in international projects for new registrations, product change registrations, and adaptations due to evolving regulations.
• Development Projects: Contribute to development projects and change committees, providing insights on approval-related matters and specifying normative and regulatory prerequisites.
• Cross-functional Teamwork: Work alongside a global team of Regulatory Affairs Managers, collaborating with Branding, Business Management, and Logistics to secure the availability of my client's products in the market.

Your Profile

• University degree in a technical, economic, business, or related field.
• Initial experience in the field of regulatory affairs, demonstrating an understanding of regulatory compliance.
• Proficient in English, and knowledge of other languages is a plus.
• Possess analytical, systematic, and goal-oriented thinking, enabling effective problem-solving.
• Familiarity with project management principles, with prior exposure to project coordination.
• High level of motivation and keen attention to detail, ensuring accuracy in regulatory processes.
• Strong team spirit, combined with excellent communication skills for seamless collaboration.

Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09

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