Cancel
Return to Job Search
Boston Scientific Ireland

Sr Reg Affairs Specialist

Boston Scientific Ireland

  • Cork
  • Not disclosed
  • Permanent full-time
  • Updated 02/04/2013
  • Recruiter
this job is expired
Apply Now

Description

At Boston Scientific, Cork, we are dedicated to improving the quality of people?s lives. We develop innovative ideas that lead to simpler, less traumatic methods of treating d

 

At Boston Scientific, Cork, we are dedicated to improving the quality of people?s lives. We develop innovative ideas that lead to simpler, less traumatic methods of treating disease and help patients to return to fuller lives sooner.

We are now interested in reviewing Applications for a Sr Reg Affairs Specialist to work at our state of the art facility in Cork, Ireland. This is a permanent position.
 
 
 
Job Purpose:
 
Responsible for Regulatory Affairs support of the site, submissions and regulatory compliance.
 
Key Responsibilities:
 

·Is an effective team leader, fully motivated to achieve and demonstrate best practices in line with the goals of the regulatory affairs department.

·Interfaces as needed with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.

·Maintains and enhances cross-functional team relationships.

·Review applicable Corporate SOP?s for effect on local regulatory processes and systems.

·Review and update of Technical Files and Design Dossiers.

·Liase with US regulatory colleagues in preparation of FDA regulatory files such as PMA?s, Supplements and Amendments, 30 Day Notices, Annual Reports and 510k?s.

·Review and approve documentation related to product release/changes through the CR process

·Provide input, review and approve artwork for labelling and DFU?s

·Participate in/support to Regulatory body audits, such as FDA and notified bodies.
·Liase and provide support to regulatory colleagues in the Intercontinental emerging markets.

·Demonstrate and actively promote highest level of professional regulatory discipline.

·Liaise with both middle and senior management on any regulatory issues relating to their area.

Typical Experience and Education Guidelines:



- Bachelor?s Degree in Engineering, Science or Quality Assurance.

-A minimum of 4 years experience in a Health Care environment is desirable

-Excellent communications skills

-Strong team member with the ability to identify and drive quality improvements

-Experience in FDA regulations, ISO 13485 and the Medical Device Directive is required.

-Good administrative/organisational ability with attention to detail is required.Please Apply at:

For Immediate Consideration CLICK HERE to apply via the Boston Scientific Career Network

Ref: 44338
Apply Now
Report This Job

Boston Scientific Ireland

Boston Scientific Ireland

25 reviews
 

View Employer Profile

Show More

Email me jobs similar to: Sr Reg Affairs Specialist

Please enter your email address

Please enter a valid email address

We use cookies to customise our website for you, giving you the best possible user experience. If you continue without changing your settings, we’ll assume that you are happy to receive this personalisation. Find out more about our cookie policy

Accept & Close