Senior Regulatory Affairs Specialist

• This role provides regional regulatory support for new product development activities and post market support. The product portfolio consists of medical devices. Responsibilities include preparing and implementing regulatory plans, supporting regulation changes and completion of regulatory deliverables. This includes managing local regulatory registrations with the global teams, impact assessments, new registrations, post-approval changes, and renewal, liaising with internal and external stakeholders in fulfillment of responsibilities. 

Essential Duties & Responsibilities

• Participates in the development and implementation of the regulatory strategy for medical devices.
• Compile, prepare and submit new registration, variations, change notifications, renewals and ensure approvals in a timely manner.
• Ensure product labeling is in line with Company Core Data Sheet and country regulations.
• Learn, drive and manage various databases and reports ensuring information is accurate and up to date.
• Maintain regulatory files in a format consistent with requirements.
• Conducts regulatory monitoring of approved products by ensuring maintained files are current, ensuring regulatory compliance, evaluates the effects of an amendment or change and takes appropriate regulatory actions.
• Work collaboratively with cross-functional team to ensure regulatory compliance and market continuity.
• Serve as key contact person for regulatory affairs and be the regulatory knowledge source for the cross-functional team.
• Communicate and, if necessary, negotiate with country Regulatory Agency to support key submissions/projects.
• Manage change controls and create strategies to support the execution and implementation of changes required by an initiative or project.
• Able to develop and implement appropriate regulatory strategies for the country to ensure business optimization.
• Participate and maintain working relationships and to provide regulatory intelligence to relevant functional and business unit's team members.
• Support the Function in driving RA operational excellence through strategizing and implementing local and/or regional continuous process improvement and/or digitization of procedures.

Education & Experience

• Bachelor's Degree in Pharmacy, Science or equivalent.
• Well-versed with new registration, license extensions, variations and renewals. Additional experience with medical device registration is an advantage.
• Minimum 6 years of relevant experience in medical devices industry.