Regulatory Affairs Specialist Point of Care (Ottawa)

JOB DESCRIPTION:

Working at Abbott

At Abbott you can do work that matters grow and learn care for yourself and family be your true self and live a full life. You will have access to:

Career development with an international company where you can grow the career you dream of.

A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity working mothers female executives and scientists.

The Opportunity

This position works out of our Ottawa Ontario location in the Point of Care Diagnostics division. Were empowering smarter medical and economic decision making to help transform the way people manage their health at all stages of life. Our Point of Care diagnostic portfolio spans key health and therapeutic areas including Chemistry Electrolytes Hematology Blood Gases Coagulation Endocrinology Cardiac Markers Neurology and Informatics. As an individual contributor the Regulatory Affairs Specialist works under the direction of the Manager Regulatory Affairs to prepare regulatory documentation for i-STAT branded products to be marketed in the United States (U.S.) and European Union (EU).

The individual has department level influence and performs specialized level work assignments and/or analyses evaluation preparation and submission of documentation for regulatory registration ensuring products and procedures comply with regulatory agency specifications. This new team member will support necessary regulatory activities required for product market entry.

The individual ensures that prepared documentation is effectively organized and presented for 510(k) submission to the U.S. Food and Drug Administration (FDA). This individual may be responsible for preparing technical files for submission to the Notified Body in the European Union.

What Youll Do

Responsible for compiling regulatory submissions such as 510(k)s and EU IVDR Technical Files and maintaining product submission documents throughout the products lifecycle for responsible countries/regions.

Responsible for compliance with applicable Corporate and Divisional Policies and procedures under the quality system.

Assists in the preparation of regulatory applications to achieve departmental and organizational objectives.

Acts as a team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.

Monitors pertinent domestic and international medical device regulations to ensure submission requirements are current.

Ensure information about such regulations and requirements especially those that are new or modified is distributed to appropriate staff.

Reviews protocols and reports to support regulatory submissions.

Comply with regulations and regulatory requirements company policies operating procedures processes and task assignments.

Maintains positive and cooperative communications and collaboration with all levels of employees customers contractors and vendors.

Provides regulatory input for responsible countries/region for product lifecycle planning.

Assess the acceptability of quality preclinical and clinical documentation for submission filing.

Assist in the review and approval of advertising and promotional items to ensure regulatory compliance with intended markets.

Required Qualifications

Bachelors degree.

Five plus years of relevant work experience.

Two plus years of related regulatory submission experience from a medical device in vitro diagnostic device and/or pharmaceutical industry.

Familiar with relevant US/international regulatory requirements for medical devices including Quality Systems standards.

Proficient with MS Office suite (Word Excel Outlook PowerPoint).

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer committed to employee diversity. Abbott strives to promote and maintain an inclusive high-performing culture that allows all employees to reach their full potential and contribute to Abbotts success. Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: