Senior Regulatory Affairs Specialist

As a Senior Regulatory Affairs (RA) Specialist, you will be pivotal in supporting the business by developing regulatory strategies for new product development and registrations. You will manage the upkeep of all regulatory documentation and ensure that regulatory and standard changes are monitored and implemented as needed. Additionally, you will step in for the QARA Manager on all RA-related matters when required.

Main Duties & Responsibilities:

• Lead a regulatory team of two, ensuring compliance with all relevant regulations and standards across the business.
• Collaborate with regulatory authorities to achieve successful product registrations.
• Develop and implement regulatory strategies for New Product Development (NPD) projects, from inception through Post-Market Surveillance, to ensure ongoing compliance and support product launches.
• Oversee the maintenance of all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, dossiers, and other regulatory submissions.
• Provide regulatory support for sales and commercial activities, addressing customer and market authority inquiries and managing expectations.
• Lead interactions with Notified Bodies on regulatory affairs (RA) matters.
• Support all communications with regulatory authorities.
• Lead regulatory transition projects and other significant regulatory initiatives.
• Lead submission strategies for NPD projects and offer guidance on R&D product development.
• Oversee regulatory decisions related to change control, assessing implications, approving or rejecting as appropriate, and maintaining accurate records of actions taken.
• Support Quality Assurance (QA) in maintaining the Quality Management System (QMS) and Good Manufacturing Practice (GMP) certification, ensuring regulatory compliance across the organization.
• Participate in auditing processes, providing regulatory guidance, and engaging in Notified Body audits.
• Support vigilance reporting and Field Safety Corrective Actions (FSCA), liaising with regulatory authorities as needed.
• Monitor and review changes in regulations and standards, assessing their impact on the business.
• Ensure that Instructions for Use (IFUs), labelling, marketing materials, and technical documentation comply with relevant regulations and standards.
• Create and maintain procedures to ensure ongoing regulatory compliance.
• Advise and train colleagues on regulatory requirements, providing support to ensure full understanding and adherence.
• Manage, support, and mentor the RA team.

For more information about the role, including individual attributes, please click here.