Abbott Project Manager, Regulatory Affairs, Abbott Point of Care, (Ottawa) in Ottawa, Ontario
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Abbott Point of Care is a global leader in providing critical medical diagnostic and informatics products for rapid blood analysis that are intuitive, reliable, and cost-effective. Our i-STAT System is an advanced, portable diagnostic tool that provides real-time, lab-quality results within minutes to accelerate patient-care decision-making as well as optimize resource utilization for our customers and the patients that they serve. The i-STAT System has the industry’s most comprehensive menu of tests in a single, with-patient platform, including tests for respiratory, metabolic, coagulation, hematology, glucose, and cardiac function. By delivering lab-quality results in minutes, on just a few drops of blood, our i-STAT System fosters a collaborative, patient-centered environment while driving improved operational performance.
Status : Regular/Full Time
Hi, my name is Susan. I lead the Regulatory team at Abbott Point of Care. I am looking to develop the next generation of Regulatory Professionals. We have new technology with new applications that will raise point of care testing to a new level. If you are a high energy individual that likes to be at the cutting edge of technology and regulatory science, join us. You will have the opportunity to interact with US and worldwide Health Authority Agencies. You will have up to the minute worldwide regulatory intelligence on the ever changing regulatory environment. Let’s navigate the global regulatory landscape to bring these much needed innovations to patients worldwide.
Determine requirements for regulatory submissions
Manage direct reports for successful execution of regulatory plans
Maintain current knowledge of relevant regulations, including proposed and final rules
Review labeling/promotional/advertising materials, and other documents to ensure compliance
Develop, manage, and execute regulatory plans for large-scale projects
Manages teams within the Regulatory Affairs Sub-Function.
Focus is on policy and strategy implementation and control rather than development.
Typically handles short-term operational/tactical responsibilities.
As the Manager of the Regulatory Affairs Sub-Function, oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Interacts with regulatory agency to expedite approval of pending registration.
Serves as regulatory liaison throughout product lifecycle.
Participates in product plan development and implementation, regulatory strategy, risk management.
Ensures timely approval of new medical devices (IVDs) and continued approval of marketed products.
Serves as regulatory representative to marketing, research teams and regulatory agencies.
Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Required Education and Experience:
BA/BS degree is required. Previous in vitro diagnostic (IVD) nucleic acid experience highly preferred
6+ years of (hands on) experience in Regulatory Affairs with FDA regulated products
Previous experience with 510(k), IDE, and/or PMA submissions
Demonstrated initiative and ability to work both independently and as a team member;
Considerable knowledge of the pertinent regulations affecting IVD’s (ie: QSR, Labeling, International Standards and Directives);
Solid analytical, problem solving and public relations skills;
Excellent English communication skills;
Strong organizational skills with a proven ability to drive for results;
Project Management and/or Supervisory experience is an asset;
Intermediate skills in MS Office (Word, Excel, Powerpoint)
Ability to take key actions and demonstrate behavioral anchors the support all Abbott leadership competencies.
Bachelor degree is required.
5-8 years of experience in a similar role, preferably within medical device/diagnostics industry.
Experience working in a broader enterprise/cross-division business unit model preferred.
Ideally candidate has submission experience with FDA or Health Canada.
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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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Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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