Medical Device Regulatory Affairs jobs in Mississauga, ON
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- Abbott LaboratoriesMississauga, ON
- $75,750–$111,100 a year
- Full-time
- Experience with preparing and filing Class II-IV Canadian medical device license applications, Investigational Testing Applications and working knowledge of the…
- MedtronicBrampton, ON
- $73,520–$91,900 a year
- Full-time
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Ryvis PharmaMississauga, ON
- Prepare written responses to deficiency letters from regulatory agencies in the stated time frame.
- Good problem-solving abilities are required to prepare…
Regulatory Affairs Specialist
Easily applyElancoMississauga, ON- $86,700–$130,000 a year
- Full-time
- Provide regulatory advice to the Canadian affiliate and launch teams on product registration, regulatory intelligence, labelling strategies, and local…
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Regulatory Affairs Specialist
Easily applyElancoMississauga, ON- $86,700–$130,000 a year
- Full-time
- Provide regulatory advice to the Canadian affiliate and launch teams on product registration, regulatory intelligence, labelling strategies, and local…
- View all Elanco jobs - Mississauga jobs
- Salary Search: Regulatory Affairs Specialist salaries in Mississauga, ON
- See popular questions & answers about Elanco
- MedtronicBrampton, ON
- $64,000–$80,000 a year
- Full-time
- Experience in regulatory affairs through internship role/s, preferably in the medical device industry.
- Define the regulatory strategy and manage regulatory…
- Sun Pharma Canada Inc.Brampton, ON
- $142,000–$173,500 a year
- Thorough knowledge of the healthcare system, disease management and medical research.
- Identify regional medical education needs and collaborate with Medical…
- BDMississauga, ON
- $85,000–$135,000 a year
- Contract +1
- Minimum 7+ years of Regulatory Affairs experience within the medical device industry, including experience with Class III and Class IV medical devices.
- AbbVieToronto, ON
- $112,000–$162,000 a year
- Full-time
- Area and HQ based Therapeutic Area medical affairs teams.
- Ensure a strong medical and scientific presence for AbbVie in investigational sites and key scientific…
- View all AbbVie jobs - Toronto jobs - Liaison jobs in Toronto, ON
- Salary Search: Pipeline Medical Science Liaison, Oncology salaries in Toronto, ON
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- Sun Pharma Canada Inc.Brampton, ON
- $142,000–$173,500 a year
- Minimum of 1 year of field medical experience is required.
- Thorough knowledge of the healthcare system, disease management and medical research.
- Fresenius Kabi CanadaToronto, ON
- $90,000–$100,000 a year
- Full-time +1
- Minimum of four years of pharmaceutical experience in a regulatory affairs capacity for pharma and/or medical devices.
- Paid float days and paid sick days.
- Alexion Pharmaceuticals,Inc.Mississauga, ON
- $107,196.80–$140,695.80 a year
- Temporary +2
- Conduct timely review of commercial/medical materials.
- Demonstrated ability to develop regulatory strategies aligned with commercial objectives.
- Insulet CorporationOakville, ON L6J 7W5
- $170,100–$218,700 a year
- Full-time
- Relevant Medical Affairs experience in the diabetes pharmaceutical or medical device industry.
- Lead, establish and execute the local medical education plans for…
- Nanz PharmaBrampton, ON L6S 5N5
- $80,000–$100,000 a year
- Full-time +1
- Monday to Friday
- Proven ability to interpret regulatory requirements, assess regulatory risk, develop strategic pathways, and provide practical business-oriented regulatory…
- Takeda PharmaceuticalToronto, ON M5H 4E3
- $127,000–$173,800 a year
- Full-time
- Participate in executing medical strategy at medical conferences (e.g., staff medical booth, interact with KOLs/HCPs, cover key scientific sessions, internally…
- RocheMississauga, ON
- $115,328–$151,368 a year
- Contract +1
- You will develop, communicate and execute robust regulatory strategies that align with global regulatory requirements.
- A Postgraduate Degree is a plus.
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Regulatory Affairs Specialist – Abbott Medical Devices (Mississauga)
Mississauga, ON
$75,750–$111,100 a year
-
Full-time
Regulatory Affairs Specialist – Abbott Medical Devices (Mississauga)
Job details
$75,750–$111,100 a year
Full-time
Mississauga, ON
Full job description
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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 is based at our Mississauga office within the Medical division and requires on‑site presence four days per week, with the option to work remotely one day.
What You’ll Do
- Prepare robust regulatory applications to achieve departmental and organizational objectives.
- Create, review and approve engineering changes.
- Act as a team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
- Review and evaluate communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards to various local affiliates.
- Maintain pertinent Canadian medical device regulations to ensure submission requirements are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are communicated to and understood by appropriate personnel.
- Interface directly with Health Canada.
- Support the product release process or reviewing and approving requests for product release.
- Review protocols and report to support regulatory submissions.
- Interface with a variety of management levels
- May lead cross-functional project team
- Support all Company initiatives as identified by management.
- Comply with Canadian regulations, Company policies, operating procedures, processes, and task assignments.
- Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
Required Qualifications
- Undergraduate university studies in a relevant field such as Life Sciences, Engineering, etc.
- Minimum of 3 to 5 years of relevant experience.
- Experience with preparing and filing Class II-IV Canadian medical device license applications, Investigational Testing Applications and working knowledge of the Canadian medical device regulations.
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Knowledge of regulatory requirements for medical devices in Canada.
- Knowledge of Canada’s Food & Drugs Act
The annual base salary for this position ranges from $75,750 to $111,100 CAD. The salary range provided applies to Canada only and does not apply to any other locations outside of Canada.
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.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
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