Job Title: Regulatory Manager
Department: Quality Assurance and Regulatory Affairs Department
Reports To: Group Quality Assurance and Regulatory Affairs Manager
General Overview of the Role
The focus of the role will be to work on the regulatory requirements of the business, especially
by working to meet corporate objectives and contribute to growth of the business. From time to
time, the role may require participation in areas of quality to ensure efficiency of business
activities, continuous improvement and compliance.
Duties and Responsibilities
• Managing global product registrations projects in accordance with country-specific
requirements and internal systems
• Determining regulatory pathways for product registration in various global countries
• Develop and maintain quality management systems for global product registrations
• Determine and maintain regulatory intelligence information and update quality
management systems as required in accordance with this information.
• Updating relevant global, regional and local databases in the product registration
• Organise and maintain reporting schedules for regulatory actions i.e. licence renewals
• Participate in medical device regulatory compliance gap analyses and implementation.
• Managing and assisting with the writing and preparation of technical documentation to
meet regulatory submission requirements e.g. CE submissions and US FDA 510k
• Ensuring medical device labelling compliance
• Managing the writing and reviewing of clinical evaluation reports
• Development and management of Post Market Clinical Follow Up (PMCF) projects as
• Distribution - Primary regulatory contact for international distributors, providing support
for enquiries and requests
• Lead and manage distributor evaluation and approval
Management of control of distributors via distributor agreements
Any other duties as assigned by Management
• Effective communicator with good interpersonal skills.
• Well organised and able to manage documentation.
• Plans, schedules, and completes tasks/projects to meet deadlines and corporate
• Project management skills (work breakdown structure, basic Gantt charting,
communication plan) to manage regulatory projects.
• Commercial awareness.
• Excellent communication and presentation skills.
• Adeptness in multinational regulatory strategy, collaboration with internal and external
stakeholders, key opinion leaders and regulators.
• Customer focused with the ability to develop and maintain good customer relationships.
• Ability to develop and manage a high-performance team.
• Ability to lead, influence and innovate within a cross-functional environment.
• Knowledge/understanding of EU Medical Device Regulations (MDR), FDA regulations
including 21 CFR 820, EU Medical Device Regulations, Canadian Medical Device
Regulations and other international regulations.
• Knowledge and awareness of the requirements of ISO 13485 and ISO 9001
Minimum of a bachelor’s degree required, preferably in a Science or Engineering field.
If you would like to find out more about this role, please forward questions along with your CV to
NO AGENCIES PLEASE