CO-OP Regulatory Affairs

Job Title

Regulatory Affairs Co-Op

Reports To

Associate Manager, Regulatory Affairs

Position Summary

This is a one-year placement student opportunity.

Working as part of the Stryker Regulatory Affairs, the successful applicant will be required to work within the HeartSine AED Regulatory Affairs team to uphold Stryker’s reputation within the global AED market as the leading provider of Public Access Defibrillators.  The position will provide experience and training in an increasingly sought-after aspect of medical device regulatory compliance.  As well as aiding in the preparation and maintenance of regulatory documentation for product registration, change assessment and new product development, the successful candidate will attend and contribute to internal design reviews and the investigation and analysis of competitor products and systems.  For applicants with an interest in medical devices, the opportunity exists to become involved in product design, development and marketing activities. 

• Assist in preparation and issue of product certification and business exception letters.

• Support product registration and renewals.

• Support the supplier change request process through assisting with regulatory change assessment and documentation of changes.

• Provide administrative support for New product development regulatory activities.

• Support the development of the regulatory quality management systems.

• Work in accordance with the Stryker Belfast Quality Management System

• Maintain awareness of the Company Health and Safety Policy and Fire Evacuation Procedur

• Assist with other regulatory tasks deemed necessary by the Associate Manager, Regulatory Compliance.
• Qualifications:

Applicants should be studying for a third level qualification in either design engineering, electronics or biomedical engineering or related discipline. High performing marketing undergraduates will also be considered for this role.

• Experience:

Essential:

• Effective written & verbal, reporting and communication skills.
• Understanding of basic technical documentation.

Desirable:

• Working within a team environment.
• Previous experience within a responsible employment role.
• Project leadership/supervision experience.

• System/Computer Requirements:

Microsoft Office applications.

• Key Competencies needed for this position?
• Team player .
• Very high work standards with excellent attention to detail.
• Good problem solving and analytical skills.
• Planning and organizational skills.
• Must be able to work under pressure and to tight deadlines.