Regulatory Affairs Associate II

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.

The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.

Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate’s role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.

www.terumoaortic.com

JOB TITLE

 

Regulatory Affairs Associate II

 

DEPARTMENT

 

Regulatory Affairs

JOB CODES

Exempt

MAIN PURPOSE OF JOB AND OBJECTIVES

 

 

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

 

Support for the regulatory side of the business to ensure compliance with corporate procedures and timely product approvals with domestic and international regulatory requirements.

 

POSITION IN ORGANISATION

 

 

 

Position in organisation can be found on the Organisational Chart via the company intranet.

KEY DUTIES

 

 

 

 

• Assist in the preparation of US, EU, and rest of world regulatory submissions as required.
• Review proposed labelling, packaging, advertising, and promotional materials after evaluating conformance to regulations.
• Review, edit and provide regulatory approval for project documentation.
• Review and analyse technical protocols, data, and reports generated by other departments.
• Partner with cross functional teams by providing preliminary regulatory guidance and support to product development teams for strategic planning, design and development, and compliance activities.
• Evaluate how design and manufacturing changes affect product registrations.
• Evaluate compliance to recognized and harmonized standards.
• Assist in SOP development, review, and initiation.
•  Stay abreast of regulatory procedures and changes in regulatory climate.
• Respond to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals in other countries.
• Provide Regulatory Affairs support during internal and external audits.
• Prepare the necessary documents to obtain Certificates of Exportability and Certificates to Foreign Government from US FDA
• Prepare and submit medical device reports or vigilance reports.
• Perform various other duties as assigned.

 

DIMENSIONS & LIMITS OF AUTHORITY

 

COMPANY

REQUIREMENTS

 

1. Must work within requirements of company handbook and policy statements.

Note: Company Handbook, Policy Statement and Authorisation of Limits do not form part of the quality system

QUALITY

REQUIREMENTS

1. Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
2. Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
3. Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.

 

 

EH&S REQUIREMENTS

 

 

 

1. Take care of your own health and safety and that of others who may  

be affected by your actions.

1. Work co-operatively to highlight issues affecting Environmental Health and Safety