Abbott Senior Specialist Regulatory Affairs, Ottawa, ON in Ottawa, Canada
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 73,000 people.
Primary Job Function:
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. Strong leadership, interpersonal, communication and organizational skills required. Must possess a high level of critical and strategic thinking skills and be a detail oriented team player with ability to influence multi-discipline teams and successfully negotiate with regulatory authorities. Must be able to set priorities as well as adapt to changing priorities. Experience with U.S. FDA 510k and/or PMA submissions and interaction with FDA reviewers required.
The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual will prepare and submit documentation needed for registration worldwide or will oversee such preparation.
Core Job Responsibilities:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
Assist in SOP development and review.
Provide regulatory input to product lifecycle planning.
Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions.
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
Determine trade issues to anticipate regulatory obstacles.
Determine and communicate submission and approval requirements.
Participate in risk-benefit analysis for regulatory compliance.
Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
Compile, prepare, review and submit regulatory submission to health authorities.
Monitor impact of changing regulations on submission strategies.
Monitor applications under regulatory review.
Monitor and submit applicable reports to regulatory authorities.
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
Maintain annual licenses, registrations, listings and patent information.
Assist compliance with product post-marketing approval requirements.
Review and approve advertising and promotional items to ensure regulatory compliance.
Assess external communications relative to regulations.
Review regulatory aspects of contracts.
Assist with label development and review for compliance before release.
Analyze the input of cumulative product changes to current product submissions.
Contribute to the development and functioning of the crisis/ issue management program
Ensure product safety issues and product-associated events are reported to regulatory agencies.
Provide regulatory input for product recalls and recall communications.
Job specific responsibilities may include the following as applicable:
Advertising and promotion
Controlled substances (e.g. DEA)
Restricted substances (e.g. REACH)
Compendial / standards
Import / export
Country specific regulatory support
Other miscellaneous responsibilities as may be required.
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.
We will provide accommodation, accessible formats and/or communication supports required due to disability during our recruitment process upon request, in accordance with the Accessibility for Ontarians with Disabilities Act (Ontario). Requests may be made by contacting our head office at 1-800-361-7852.
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.
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Undergraduate university Degree (4 year program), or equivalent experience (e.g.B.Sc., B. Eng), Science, mathematics, engineering or medical fields are preferred.
Typically requires 3+years of experience in a regulated industry (e.g. medical products, nutritionals) to develop the competence required to meet the responsibilities of the position.
2+ years of experience in regulatory preferred but may consider quality assurance, research and development support, scientific affairs, operations or a related area.
Certification is an asset (e.g. RAC from the Regulatory Professionals Society).
Higher education may compensate for years of experience.
Communicate effectively verbally and in writing with diverse audiences and personnel.
Write and edit technical documents.
Work with cross-functional teams and individuals from various disciplines and cultures.
Negotiate internally and externally with regulatory agencies.
Pay strong attention to detail and think analytically.
Create project plans and timelines and manage projects.
Organize and track complex information.
Exercise judgment within broadly defined practices and polies in selecting methods, techniques and evaluation criteria for obtaining results.
Ability to exercise good and ethical judgment within policy and regulations.
Ability to use in-depth knowledge of business functions and cross group dependencies/relationships.
Define regulatory strategy with supervision.
Follow scientific arguments, identify regulatory scientific data needs and, with supervision, solve regulatory issues.
Regulatory knowledge of regulatory history, guidelines, policies, standards, practices, requirements and precedents.
Knowledge of regulatory principles and requirements of applicable product laws.
Knowledge of regulatory submission/registration types and requirements.
Knowledge of GxPs (GCPs GLPs, GMPs).
Knowledge of principles and requirements of promotion, advertising and labeling.
Knowledge of international treaties and regional, national, local and territorial trade requirements, agreements and considerations.
Knowledge of domestic and international regulatory guidelines, policies and regulations and ethical guidelines of the regulatory profession, clinical research and regulatory process.
Broad knowledge of various technical alternatives and their potential impact on the business.
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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