Regulatory Affairs Specialist (International)

St. Jude Medical, Inc. (NYSE:STJ) is a global leader in the design and development of cardiac management devices such as pacemakers and implantable defibrillators. Our products help save lives in more than 130 countries and we have over 20 operations and manufacturing facilities worldwide. We were named by Fortune magazine as one of the top 5 most admired medical device companies. At

Our Regulatory group is seeking a talented and skilled International Regulatory Affairs Associate or Specialist. Complete job description is below. If you are interested, please complete the required Q&A below along with sending your resume as a WORD attachment

 

Regulatory Affairs (International)

 

Will work directly with International Regulatory Affairs Specialists to support International submission activities, and will have delegated responsibilities to assist in the preparation of product submissions worldwide to support timely approvals of implantable products.

 

Responsibilities will include, but are not limited in scope to the following activities:

?  Management of CFG / COE process (inclusive of legalization & notarization) to compliment world wide registration activities.

?  In consultation with RA Specialists organize product releases ensuring effective and efficient distribution of product world wide.

?  Works with RA Specialists to collate and complete documentation of manufacturing changes to meet regulatory compliance of Quality System.

?  Works with the RA Specialists and assists in collating documentation required for various product registrations worldwide.

?  Supports activities related to electronic transferring of product submissions, approvals, and other country-specific information required for International Affiliates located world wide.

 

Will be required to provide team input into ensuring that departmental goals are met and will take an active role in the continuous process improvement activities within the department, assuring that the quality of service provided meets both internal and external customer requirements.

 

This is an ideal opportunity for a Clinical Research Associate looking for a career transition within the medical device industry.

 

Requirements / Education: Currently studying or having completed a degree in any of the named fields: bioscience, bioengineering, nursing, international studies, political science or related field inclusive of clinical experiences.

 

Solid verbal and written analytical / problem solving, communication, inter-personal and presentation skills are essential.

 

Advanced personal computer skills including spreadsheet, word processing and data base management.

 

Desired Requirements: Relevant experience(s) in Regulatory Affairs, Clinical Affairs and / or Quality Assurance desirable, but not essential.

 

To apply, please send resume as WORD attachment, along with answers to the following questions:


 

1.) Why are you seeking employment at this time?  If you are working, why are you looking to leave your current role?

 

2.) Discuss your most difficult regulatory affairs submissions project?

 

3.) This job requires someone with strong multi-tasking skills.  Provide an example where you successfully handled and prioritized multiple tasks.

 

4.) Salary requirements?

 

5.) If hired, how soon can you start and are you able to provide legal right to work documentation?