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Job Details

Regulatory Affairs Specialist

Company: Thornshaw Recruitment
Location:
Reference: TD9522
Closing Date: 18 Nov 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

My client a leading medical device company currently have a new opportunity for a Regulatory Affairs Specialist. This is a permanent opportunity.

Requirements:

My client a leading medical device company currently have a new opportunity for a Regulatory Affairs Specialist.   This is a permanent opportunity.

The Role/Responsibilities.

JOB PURPOSE: The Regulatory Affairs Specialist is responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for Medical products globally


KEY RESPONSIBILITES: Key responsibilities will include (but are not limited to) the following:

• Apply technical solutions to problem solving

• Apply technical solutions to quality improvement projects

• Use technical writing skills to clearly describe technical information

• Analyze customer complaints, identify trends and execute corrective actions

• Review and assess of change control activities for potential impact on current regulatory filings.

• Maintenance of Regulatory procedures to ensure continued compliance.

• Ensure continual Quality System compliance by adherence to established and evolving internal requirements.

• Serves as RA team member for promotional materials review, experimental designs, data analysis, risk management and product labeling as they relate to registration and commercialization of medical devices. .

• Support Regulatory inspections at the site as directed.

• Liaise with other departments to ensure correct supporting data generated and provided in a timely manner.

• Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives

Qualifications/Experience:
Engineering/Science qualification with 2/3 years of working within R&D/QA/RA in a medical device environment.

• 2/3 years experience in R&D, QA/RA, Validations – essential • 2/3 years experience in Risk, Clinical and Biocompatibility – an advantage

• Excellent technical writing experience within a medical device environment - essential

• Attention to detail and accuracy – essential

• Fluent English, both written and oral - essential

• Ability to work well under deadlines and pressure

• Problem solving skills for developing creative solutions and meeting objectives are required.

• Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel);

• Excellent analytical ability

• The ability to prioritize tasks and be able to manage several projects and tasks simultaneously; and the ability to interface with all levels of management. • Travel up to 10%

 

For more deatils please contact me on +353 1 2784671 or email your CV to tdunne@thornshaw.com 

Apply for this job: Regulatory Affairs Specialist

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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