Global Data and Documents Regulatory Operations Specialist

Global Data and Documents Regulatory Operations Specialist (x2)

Are you ready to take your regulatory expertise to the next level? Our client is seeking a dynamic and detail-oriented Global Data and Documents Regulatory Operations Specialist to join their innovative team. This exciting opportunity is offered as a hybrid position, with three days onsite, blending flexibility with collaboration.

Contract Duration: 1 position is for 1 year and the other is for 6 months
Location: Hybrid - 3 Days Onsite

What You'll Do:

As a pivotal member of our cross-functional product development teams, you will play a crucial role in ensuring compliance with applicable regulations and standards.

Your responsibilities will include:

• Regulatory Guidance: Participate in and advise teams on regulatory requirements for new products and solutions.
• Submission Coordination: Plan, generate, and coordinate regulatory submissions, ensuring all necessary information is included.
• Testing Coordination: Oversee testing processes that support regulatory submissions.
• Labelling Review: Review and approve product labelling and marketing communications to ensure compliance.
• Maintenance of Filings: Maintain existing regulatory filings and licences while managing updates and change control processes.
• Strategic Advisement: Advise product design teams on regulatory strategy based on market trends and competitive landscape.
• Planning & Compliance: Develop regulatory plans for new product introductions and changes, ensuring ongoing compliance.
• Risk Assessment Support: Assist in the development of regulatory plans, guidance on risk assessment, and corrective actions for product registrations, including CE marking and clinical evaluations.
• Facilitation of Submissions: Develop and facilitate regulatory submissions for both new and existing products and solutions.
• Marketing Material Validation: Review and validate marketing and labelling materials for compliance.

Qualifications:

To thrive in this role, you'll need a blend of education and experience:

• A degree or equivalent experience in Regulatory Affairs or a related discipline.
• A proven track record of specialised skills developed through rigorous training and substantial on-the-job experience.

Skills & Attributes:

• Detail-Oriented: Exceptional attention to detail is a must!
• Collaborative: Ability to work effectively within cross-functional teams.
• Strategic Thinker: Strong analytical skills to navigate regulatory complexities and market demands.
• Excellent Communicator: Clear and concise communication skills for effective collaboration and documentation.

Why Join Us?

• Impactful Work: Contribute to the development of innovative products that can shape the future.
• Collaborative Culture: Work alongside passionate professionals in a vibrant and supportive environment.
• Professional Growth: Opportunities for career advancement and continuous learning.

Adecco is a disability-confident employer. It is important to us that we run an inclusive and accessible recruitment process to support candidates of all backgrounds and all abilities to apply. Adecco is committed to building a supportive environment for you to explore the next steps in your career. If you require reasonable adjustments at any stage, please let us know and we will be happy to support you.