Senior Regulatory Specialist

The Senior Regulatory Specialist is responsible for managing an efficient program to ensure that all regulatory activities for the companies products are achieved to an agreed schedule in EMEAP. The Senior RA Specialist will work with the Regulatory Affairs Management team, colleagues and cross-functional team to develop and implement strategies that will ensure the timely introduction of products onto the market, coordinate and oversee preparation of complete and scientifically sound regulatory submissions, when applicable, lead interactions and discussions with internal and external stakeholders, including regulators, GSM, R&D, Government Affairs and Legal to resolve issues arising during the regulatory submission process and post-market to ensure a timely approval process.  

Core Job Responsibilities

• Formulate, develop and manage a program to enable all EMEAP registrations, when applicable, are completed efficiently and to an agreed schedule.
• Manage a roll out program for existing products and new launches.
• Work with the Regulatory Management team, Regulatory Affairs colleagues, and cross-functional team to develop and implement strategies that will ensure the timely introduction of products onto the international market. 
• Manage the creation and development of Technical files and/or submission documentation for ADC devices in accordance with regulatory requirements, including MDR 2017/745 & IVDR 2017/746.
• Provide guidance to Regulatory colleagues in coordinating the preparation of regulatory submissions.

Sample Requests and Label Copy: 

• Manage a program to ensure efficient scheduling of all sample requests.
• Review baseline labelling & translations, marketing and training materials for regulatory compliance within EMEAP.

General:

• Ensure that all documentation is correctly completed to a high standard of quality & clarity.
• Maintain awareness of regulations and guidelines governing the Company and communicate their impact to Global RA and AQR when appropriate. Advising in the interpretation and application of MD and IVD requirements, as well as the planning and implementation of new and updated regulations.
• Responsible for implementation of new requirements when required.  
• Open and maintain regular communications with any contacts requiring any regulatory involvement.
• Responsible for maintaining the effectiveness of the Quality System at the site location in accordance with the companies requirements and applicable regulations.
• Check and complete own training records/status in a timely manner and performs functions in a manner that is compliant with the training system.
• Adhere to all company policies and procedures and training requirements.

Position Accountability / Scope

• Responsible for ensuring the timely registration and registration maintenance of all current and new products with the appropriate regulatory authorities, if applicable.
• Responsible for regulatory compliance activities , including but not limited to, review of advertising & promotional materials, review of labelling translations, awareness & assessment of emerging regulations and guidelines, implementation of new regulations that are in scope of regulatory affairs, maintaining positive and effective relationships with internal & external stakeholders. 

• Educated to degree level or equivalent preferably in a scientific discipline e.g. Chemistry, life Sciences, Biology.   
• Knowledge of the regulatory environment, hands on experience in the registration of medical devices.
• Proven experience of working with Government regulatory stakeholders. 
• Ability to establish excellent working relationships with regional and global internal stakeholders and navigate complex matrix environments.
• Strong communication skills (verbal and written).
• Languages: French required. English proficiency level. Dutch is a plus.

• Work on breakthrough innovations
• Recognized as great workplace in dozens of countries around the world
• Meaningful, challenging work every day
• Creates and employs breakthrough science
• Fair remuneration package