Senior Regulatory Affairs Associate / Senior Regulatory Affairs Associate

Join Our Team as a Senior Regulatory Affairs Associate

Are you ready to take the lead on global regulatory compliance, shape regulatory strategy, and support the next generation of regulatory professionals? Proclinical is seeking a Senior Regulatory Affairs Associate to support global regulatory compliance and product registration for medical devices. In this pivotal role, you will play a key part in ensuring adherence to international regulations, managing the regulatory lifecycle of products, and providing strategic guidance on regulatory challenges. This position also involves mentoring team members and collaborating with cross-functional teams to achieve business objectives.

Responsibilities:

• Prepare and submit registration documents for regions including the US, Canada, EU, Australia, New Zealand, and the Middle East.
• Maintain accurate and complete regulatory documentation.
• Monitor and adapt to changes in legal and regulatory requirements, updating strategies as needed.
• Conduct risk assessments for regulatory changes and implement mitigation strategies.
• Review and approve marketing materials, product labeling, and user manuals for compliance.
• Manage product updates, such as labeling or formulation changes, and submit variations to regulatory bodies.
• Maintain and update product Technical Files in compliance with ISO 13485, MDSAP, EU MDR, and other applicable standards.
• Liaise with internal teams and external stakeholders on regulatory documentation and registration progress.
• Ensure timely submission of re-registration renewals to avoid certificate expirations.
• Develop and update regulatory procedures to ensure compliance with legal and regulatory requirements.
• Support regulatory actions, including recalls and adverse event reporting.
• Provide guidance to team members on regulatory policies and procedures.
• Identify and implement process improvements to enhance regulatory efficiency.
• Participate in audits and collaborate with cross-functional teams to meet regulatory requirements.

Key Skills and Requirements:

• Strong knowledge of medical device regulations, including FDA, EU MDR, TGA, Health Canada, and Medsafe.
• Experience in preparing regulatory submissions and managing regulatory information systems.
• Familiarity with ISO 13485, EU MDR, MDSAP, and related standards.
• Excellent communication and project management skills.
• Proven ability to work independently and collaboratively in a fast-paced environment.
• Analytical mindset with the ability to assess risks and propose solutions.
• Leadership and mentorship abilities to support team development.
• Resourcefulness in addressing regulatory challenges and achieving business outcomes.

If you are interested in applying for this exciting opportunity, please apply online using the form below. Only applications matching the job profile will be considered.

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

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