Fixed Term Contract
This role comes to market from a global leader in the design and manufacture of electromechanical products as well as class I and II medical devices. With the business continuing to invest in the development of next generation technology you will be helping to ensure their new products are successfully registered and compliant for sale in multiple regions around the world.
Joining as Regulatory Affairs Coordinator you would focus on pre-market registration activities for a number of international markets, completing the technical documentation necessary for the legal compliance, licensing, and marketing of company products.
Further responsibilities will include:
- Identify and communicate regulatory changes within the business ensuring continued compliance with all relevant regulatory requirements.
- Develop and review product technical documentation and medical device files as well as regulatory dossiers required for regulatory compliance and registration with the notified bodies and authorities.
- Manage the Engineering Change request process where regulatory actions are required
- Carry out post-market surveillance and Field Safety Corrective Actions where required.
To carry out this role they are seeking a professional with 2-3 years + experience in either the medical device or pharmaceutical sector. Further skills/experience required includes:
- Degree certified in engineering or a scientific subject such as biomedical science, chemistry, or pharmacy
- 2 to 3 years industry experience within regulatory affairs, quality, or R&D within the medical device or pharmaceutical sectors
- Experience with product registration, medical device file and / or technical compliance activities
- Knowledge of EU MDD/MDR, ISO 13485 and MDSAP requirements
- Knowledge of active medical devices, risk assessments, post-market surveillance and quality compliance as they relate to product registrations.
Offering a great work environment this exciting position comes from a business that really values its people. Company benefits include a free coach service from their local train stations increasing access from the local area, central and east London as well as an onsite subsidised canteen and an onsite nursery. Employee benefits include double matched contributory pension to 12% and private healthcare after your first year.
Please note the employer has implemented a number of measures to make sure their site is Covid Safe and is also currently offering employees the choice to work from home or onsite as they feel most comfortable with this being continuously monitored by the business in line with government advice.
Long term the business is reviewing their work from home policy with greater flexibility expected to stay in place. Whilst this role is not open to complete remote working, the business are happy to consider applications from those that would require the flexibility to partially work from home.
To apply please submit your CV for consideration.