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

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

QUALITY

REQUIREMENTS

EH&S REQUIREMENTS

be affected by your actions.

QUALIFICATIONS & EXPERIENCE

It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.