Senior Regulatory Affairs Specialist.
Your new company
This new exciting client takes pride in the quality of their products and the service they provide to their customers. This is a global company and they work across 25 countries, as such, understanding the varieties in regulations and quality standards is key to maintaining their highest standards.
Due to expansion they are now recruiting for an experienced Senior RA/QA Specialist to join their diverse team. The role will follow the regulatory strategy for assigned corporate projects and write, file and obtain approvals for international regulatory submissions.
Your new role
- Comply with the regulatory requirements and international standards within the region.
- Prepare registration dossiers for approval in EU & ROW
- Initiates IFUs and required product labelling in line with relevant EU & ROW requirements.
- Prepares Technical Files for CE approval
- Represents the perspective of regulatory affairs to the company.
- Interprets general business objectives and effectively presents information to manager and regions.
- Reviews and approves product labelling.
- Liaise with Competent Authorities and Ministries of health within the region
- Provide input to Regulatory Affairs Impact Documents (RAIDS) from an EU & ROW perspective.
- Maintain good visibility of Distributers processes and importation requirements
- Proactively acts as a resource to the regions on RA / QA issues and proposes changes to minimise risks and enhance quality, reliability, safety and productivity.
- Maintains ISO 13485 certification
- Perform audits on 3rd party distributers in the EU & ROW.
- Perform tracks and records recall activities
- Writes SOP
What you'll need to succeed
- Understanding of ISO 13485 requirements and EU medical device regulations.
- Ability to read and understand technical material.
- Auditing experience
- Excellent attention to detail & organization skills
- Excellent written and verbal communication skills.
- Computer literate, with intermediate skill in the use of Word, Excel and Outlook, and some knowledge of relational database systems, e.g. Agile Project Management system.
- Ability to work effectively either alone or as part of a team. Managing time effectively and completing tasks on time with general supervision.
- Experienced at reviewing and approving product labelling.
- Flexible and able to self-manage multiple priorities.
- Able to work effectively in multinational/multicultural environments.
- Flexibility to work across the UK sites, full UK driving license.
- Bachelor's degree in a scientific or technical discipline and working knowledge of medical device regulations
- Representation on cross-functional project team
What you'll get in return
An annual salary between £45,000 - £55,000 (Depending on Experience)
An attractive bonus
Other exciting benefits
The opportunity to be a part of a global growing organisation.
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.
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