Regulatory Affairs Specialist - Medical Devices
- Recruiter
- Elevate Platform Limited
- Location
- Inverness
- Salary
- 29.00 - 37.00 GBP Hourly
- Posted
- 15 Aug 2017
- Closes
- 23 Aug 2017
- Sectors
- Admin, Secretarial & PA
- Contract Type
- Contract
- Hours
- Full Time
Regulatory Affairs Specialist / Inverness / 12 Months Contract / 29 to 37 GBP (Per Hour)
This role will support the RA Project Leads for new blood glucose monitoring system development projects.
Responsibilities will include:
- Supporting the project RA Lead during characterization, verification & validation, labelling & claims development.
- Assisting in preparation of pre-market applications to regulatory agencies.
- Researching, consolidating and communicating global regulatory requirements to enable development of global regulatory strategies.
- Partnering with global regulatory affiliates and providing documentation to support international applications for new products/maintenance of existing product licenses.
- Assisting in the development of best practices for Regulatory Affairs processes
Essential criteria include:
- Demonstrated experience working in a Regulatory Affairs role within the medical device industry
- Degree qualified, preferably in a scientific or technical field
- Familiarity with medical device regulations in US and/or EU
- Excellent verbal and written communication skills
- Strong organizational, interpersonal, and problem solving skills; detail oriented
- Ability to work independently and collaboratively with minimal supervision
- Working knowledge of MS Office programs (Word, Excel, PowerPoint, Outlook) and electronic document management systems.
The Client
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.
This role will support the RA Project Leads for new blood glucose monitoring system development projects.
Responsibilities will include:
- Supporting the project RA Lead during characterization, verification & validation, labelling & claims development.
- Assisting in preparation of pre-market applications to regulatory agencies.
- Researching, consolidating and communicating global regulatory requirements to enable development of global regulatory strategies.
- Partnering with global regulatory affiliates and providing documentation to support international applications for new products/maintenance of existing product licenses.
- Assisting in the development of best practices for Regulatory Affairs processes
Essential criteria include:
- Demonstrated experience working in a Regulatory Affairs role within the medical device industry
- Degree qualified, preferably in a scientific or technical field
- Familiarity with medical device regulations in US and/or EU
- Excellent verbal and written communication skills
- Strong organizational, interpersonal, and problem solving skills; detail oriented
- Ability to work independently and collaboratively with minimal supervision
- Working knowledge of MS Office programs (Word, Excel, PowerPoint, Outlook) and electronic document management systems.
The Client
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.