Regulatory Affairs Manager - Medical Device

Purpose:

The management of the company and products compliance to all relevant regulations and standards encompassing a range of different product types including but not limited to Medical Devices and accessories. Management and responsibilities regarding Export Registrations of all product types within the International Group area.

Key Responsibilities:

• Manage regulatory compliance and registrations of devices manufactured by the company and those products subcontract manufactured for the company.
• Compile necessary documentation for registration of company products in markets throughout the International region. Manage submissions to ensure completion and confirmation of market registrations.
• Manage Export registration schedule; record requests for new projects, discuss with Sales Director to schedule work and distribute work amongst self and team.
• Advise on regulatory and associated requirements and provide guidance on testing to meet relevant regulatory requirements throughout the International Group region.
• Respond to enquiries from customers, other members of staff, national authorities, customs and imports, and trading standards.
• Act as cover to the QA Manager and RAQA Director when required.

Key Qualifications:

• Undergraduate degree in a scientific discipline
• Trained requirements of ISO 13485 2016 , ISO 9001 , GMP
• Certified Internal and 2^nd Party Auditor
• Trained in requirements of the MDR

Dimensions and Limits of Authority:

• Authority to:
• Compile registration documents and submit for Export registrations
• Liaise with government authorities on behalf of the company
• Discuss confidential data with consultants and solicitors
• Decide on necessary data required to construct Technical files

Key Experience:

• Minimum of 5 years’ experience in a Medical Device Regulatory Affairs role
• Methodical, accurate and consistent attention to details
• Knowledge of the EU Medical Device Regulations
• Knowledge of Global Regulatory registration submissions and maintenance
• Experience working with Electronic Medical devices highly beneficial.
• Experience in providing training to company staff as appropriate

Key Contacts with the role, department and company:

• Influence R&D testing protocols, schedules and methods
• Influence Export registration schedule through coordination with commercial Directors
• Work with distributors, consultants and local authorities to achieve successful product registration
• Negotiate as appropriate with raw material suppliers and regulatory authorities
• Instruct as appropriate manufacturing facilities on approved raw materials

Key Skills:

• Communicate effectively to resolve issues
• Ability to influence and guide all direct reports where appropriate
• Excellent written and spoken English
• Meticulous data review
• Self-learner
• the ability to communicate complex ideas logically and simply
• patience and persistence
• ability to manage multiple complex projects
• Deadline driven – ability to pick up new concepts and regulations quickly
• Adaptable -work in a fast paced ever changing environment