Abbott Manager Regulatory Affairs in Ottawa, Canada
Abbott Point of Care is a market leader in point of care testing, based in Ottawa, Ontario and Princeton, New Jersey. The i-STAT System offers a diverse menu of blood gas, chemistry, coagulation and cardiac marker assays, which facilitates improved patient care by ease of use and rapid time to accurate results. With annual growth in sales, Abbott Point of Care is a dynamic and exciting work environment.
As an individual contributor of the Regulatory Affairs team, the candidate will contribute to the team’s success by providing support for the regulatory department to ensure efficient and compliant business processes in a medical device environment.
The individual has department/group/site level influence and is generally recognized as an expert resource within the department. The individual may share knowledge and expertise with others in support of team activities. The individual may identify data needed, obtain these data and ensure that they are effectively presented for the registration of products worldwide.
Knowledge, Skills & Abilities:
Execute and manage technical and scientific regulatory activities.
Must function independently as a decision-maker on regulatory issues and must assure that deadlines are met.
Effectively communicate, prepare and negotiate both internally and externally with various regulatory agencies.
Properly interpret and apply regulatory requirements.
Interfaces with a variety of management levels on significant matters, often requiring the coordination activity across organizational units.
May lead a cross-functional or cross-divisional project team.
Provides technical leadership to business units.
Minimum 7 years’ relevant experience in a regulated industry.
Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
Regulatory agency structure, processes and key personnel.
Principles and requirements of applicable product laws.
Submission/registration types and requirements.
GxPs (GCPs, GLPs, GMPs).
Principles and requirements of promotion, advertising and labelling.
Domestic and international regulatory guidelines, policies and regulations (including Europe).
Ethical guidelines of the regulatory profession, clinical research and regulatory process.
Drive gap analysis for new regulations.
- Bachelor’s degree (or equivalent) in Science or Engineering.
Abbott Canada is committed to the hiring, advancement and fair treatment of individuals without discrimination based on factors such as race, sex, colour, ethnic or national origin, religion, disability, age, citizenship, family or marital status, political beliefs, sexual preference or other factors included in human rights legislation.
Our diversity goals for recruitment, hiring, and retention are embedded in our corporate goals, and our diversity initiatives are supported by the highest level of the organization.
We strongly believe that a diverse workforce fosters more creative and innovative thinking throughout the organization. Creating an inclusive environment, where everyone is respected and valued, enables us to leverage our diversity as a business driver and strengthens our position as a global leader.
Abbott strives to promote and maintain an inclusive, high-performing culture that allows all employees to reach their full potential and contribute to Abbott’s success.
APOC Point of Care
Canada > Ottawa : 185 Corkstown Road
SIGNIFICANT WORK ACTIVITIES:
Keyboard use (greater or equal to 50% of the workday)
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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