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Regulatory Affairs Officer Jobs

Regulatory Affairs Specialist - Medical Device
By ClinChoice At Greater Toronto Area, Canada
Document review of product changes due to EU MDR impact and the management of any required submissions.
Extracting available documents from the document management databases and operational systems to assist in the preparation of dossiers.
Minimum of one year of working experience in Medical Device industry specific to Health Canada
Knowledge of ISO13485, EU MDD/MDR, and Health Canada MDEL/MDL applications is required
Strong organizational skills including attention to detail, good planning and communication skills are required
Must possess excellent written and verbal communication skills
Director Of Regulatory Affairs - Medical Device/Pharma
By Akkodis At Scarborough, Ontario, Canada
· 10 to 12 years working experience
Experience working directly with the FDA on regulatory filings/strategy is required
· Experience with electronic submissions/the electronic submission process
Knowledge of how regulatory agencies operate, structure and process
Staying updated on regulatory requirements:
This is on site, 5 days a week role – for Canada, Scarborough location.
Regulatory Affairs Specialist Jobs
By DMC Recruitment Group At Brampton, Ontario, Canada
Proficiency in document management and record-keeping.
1-3 years of experience in regulatory affairs within the chemical distribution or related industry.
Strong knowledge of local, state, and federal regulations governing chemical distribution and safety.
Excellent communication and interpersonal skills.
Detail-oriented with strong analytical and problem-solving abilities.
Experience working in pharmaceuticals, food & beverage, essential chemicals or lubricants is an asset.
Regulatory Affairs Jobs
By Tag At Greater Toronto Area, Canada
•Experience in the delivery and management of complex quality assurance solutions
MUST HAVE EXPERIENCE AND INDICATED ON RESUME WITH MLR SUBMISSIONS, PAAB and VEEVA PROMOMATS SUBMISSIONS
•A Bachelor’s degree or equivalent experience is required
•Over 6 years’ experience in print and/or digital, or regulatory Quality Assurance environments
•Medical, pharmaceutical, or Life Sciences marketing experience preferred
•Excellent client facing and customer service skills
Regulatory Affairs Associate Jobs
By Kelly Science, Engineering, Technology & Telecom At Markham, Ontario, Canada
Excellent communication (verbal/written), interpersonal, and organizational/ time management skills are required.
Maintains up-to-date information regarding the Health Canada requirements to ensure timely review and approval of product submissions.
Manages the archiving of regulatory submissions to ensure ease of retrieval.
Minimum of four (4) years of Canadian Regulatory Affairs experience is required.
Working knowledge of Health Canada laws and regulations of OTC, NHPs and cosmetics is required.
Experience with Plain Language Labelling for OTC and NHP is an asset.
Quality Assurance And Regulatory Affairs Analyst
By Intellijoint Surgical Inc. At Kitchener, Ontario, Canada
Experience working within a Quality Management System (QMS)
Strong organizational, time management, and prioritization skills.
Support system administration of Quality Management System software.
Skills and Experience to Enable Success:
A continuous learner that builds on their existing knowledge of medical device and biomedical technology regulations
Collaborate with cross-functional teams and interface with external parties to meet quality requirements within project timelines.
Director Of Regulatory Affairs
By Akkodis At Scarborough, Ontario, Canada
· 10 to 12 years working experience
Experience working directly with the FDA on regulatory filings/strategy is required
· Experience with electronic submissions/the electronic submission process
Knowledge of how regulatory agencies operate, structure and process
Staying updated on regulatory requirements:
Preparing and submitting regulatory submissions:
Associé(E), Affaires Reglementaires / Regulatory Affairs Associate
By Pfizer At Kirkland, Quebec, Canada
Strong organizational skills (project and records managements)
Build general scientific knowledge of assigned portfolio and of cross-functional roles/responsibilities
Build and maintain knowledge of Regulatory requirements and Health Canada regulations, policies/guidelines
Strategic Planning and Product Lifecycle Management
Manage Regulatory filings & review/approval process for products in portfolio to secure timely approvals
Manage and summarize ongoing issues and HC queries to develop plan of action, along with team prepare response and ensure resolution
Vp, Regulatory Affairs Jobs
By Aviso Wealth At Toronto, Ontario, Canada
Extensive experience (minimum 12-15 years') in the wealth management industry
Strengthen and enhance compliance processes, supervisory controls, and risk management insights through technology
Delivery of key messages to senior management of Aviso, Credit Union executives and board of directors
Strong presentation skills and public speaking experience
Maintain a current and advanced knowledge of all regulations that pertain to the functions they administer and provide thought leadership
Strong and demonstrable experience in plain language writing and communication style
Director – Regulatory & Technical Affairs
By Canadian Poultry and Egg Processors Council At Ottawa, Ontario, Canada
Facilitate discussions on interpretation and enforcement issues with CFIA headquarters, and potentially CFIA Regional Directors on issues affecting members.
Work with national producer groups on supply chain issues affecting food safety and animal health & welfare.
Participate as required, in industry, government and stakeholder meetings on behalf of CPEPC and represent its members.
Director – Regulatory & Technical Affairs,
Major areas of focus are:Food Safety and Animal Health & Welfare.Specific focuses include:
Regulatory Affairs Associate Jobs
By Regxia Inc. At Vaughan, Ontario, Canada
Adverse event reporting – assess reportability, prepare and submit reportable ADRs, record management, annual safety reports, etc.
2-5 years regulatory affairs work experience/education.
Strong organizational ability and management of multiple priorities combined with proven ability to meet strict and established timelines.
Functional, previous experience in regulatory affairs submission preparation and familiarity with TPD/FDA/ICH guidelines.
Good working knowledge of current Canadian Food and Drug regulations, GMP guidelines and policies.
ECTD submission experience (familiarity with Lorenz docuBridge is an asset).
Regulatory Affairs Manager Jobs
By BioMedica Diagnostics Inc. At Windsor, Nova Scotia, Canada
University Degree/Professional Designation or equivalent learning and experience in a related discipline (i.e. Management; RAC)
Effective communication with all stakeholders, including customers and government authorities. Abilities should include excellent presentation, writing, and editing skills.
Fundamental Skills, Abilities & Attributes
Manage and lead recalls vigilance procedures, health risk assessments.
Strong knowledge and understanding of cGMP, ISO 13485, MDSAP and IVDR guidelines, policies, and regulations
Technical knowledge of in-vitro diagnostic products
Director Regulatory Affairs Jobs
By Altasciences At Canada
Critical thinking skills and ability to acquire and apply knowledge quickly;
Lead, manage and prepare clinical trial submissions;
Lead, manage, prepare, and submit meeting requests and meeting information packages to health agencies;
Lead, manage, prepare, and submit controlled correspondence to regulatory agencies;
8+ years of regulatory experience in an industry setting;
Strong knowledge of drug development and regulatory policy;
Regulatory Affairs & Quality Specialist
By Endocision At Montreal, Quebec, Canada
Maintain all Quality Management meeting documentation.
Maintain and issue training requirements to company.
Maintain working knowledge of ISO 13485 and ISO 14971.
Maintain in depth knowledge of regulatory guidance documents.
Experience in documentation for Class II/III or IV medical devices, experience with 510(k) or De Novo Submissions a plus.
Experience with ISO 13485 or ISO 9001, experience with ISO 14971 a plus.
Regulatory Affairs Specialist Jobs
By Brunel At Prince Edward Island, Canada
Excellent organization, time management, and prioritization skills.
Provide or facilitate training for operators and managers on quality systems and related issues.
Preferably, have a minimum of 5 years of experience in a quality or regulatory role within the pharmaceutical industry.
Preferably, possess at least 3 years of experience in releasing drug/NHP products to the Canadian Market.
Demonstrated knowledge of ICH Guideline, FDA-CFR regulations, Health Canada, and other relevant regulations.
Strong written and verbal communication skills.
Regulatory Affairs Manager Jobs
By JAMP Pharma Group At Boucherville, Quebec, Canada
Experience in team and project management.
Manage safety updates to product monographs.
Maintain up-to-date knowledge of applicable company SOPs, guidelines, and work instructions as they relate to product labeling.
Understand the BPM audit process and requirements.
Minimum 3 years' experience (pharmaceutical industry, an asset).
Strong communication and negotiation skills.
Head, Regulatory Affairs, North America
By PSI CRO AG At Toronto, Ontario, Canada
Prior experience in a managerial function (i.e. line management)
Management of the Regulatory Affairs staff in North America
Consulting Quality Management in North America-specific regulatory aspects during the development and implementation of internal audit plans (shared responsibility)
Extensive experience in regulatory aspects of clinical research with profound knowledge of regulations pertaining to clinical trials in North America
Minimum 5 years of proven experience within Regulatory Affairs for clinical research
Strong attention to detail skills
Global Regulatory Affairs & Advisory Manager – Chemicals
By lululemon At Vancouver, British Columbia, Canada
Previous Project Management experience is an asset
Previous experience with the development and implementation of a Restricted Substances List or related chemicals management programs is an asset
In collaboration with the Chemicals Management Team, ensure regulated standards are reflected in annual updates to lululemon’s Restricted Substances List
Experience with national and/or international chemical laws and regulations applicable to adult apparel and accessories, , foods, electronics and equipment
Experience with regulatory, government and industry or standards organizations
Experience with legal and regulatory action is desired
Vp, Health Policy And Regulatory Affairs
By Kelly Science, Engineering, Technology & Telecom At Greater Toronto Area, Canada
Strong leadership and management skills and demonstrated ability to manage, support and motivate self-and others, sharing enthusiasm for organizational goals.
Communicate effectively, both orally and in writing, with experience preparing and adapting messaging that corresponds to the appropriate audience.
Facilitation and committee experience required, including the demonstrated ability to drive consensus at the senior leadership level.
Demonstrates good judgement as well as excellent people skills.
Identify and facilitate policy alignment as appropriate with health professional organizations, NGOs, allied industry associations, international associations, and academia.
Ensure members are informed and engaged on policy and regulatory issues impacting the consumer health product sector.
Associate Director, Regulatory Affairs Cmc
By GSK At Mississauga, Ontario, Canada
Project management experience with excellent interpersonal, presentation and communication skills.
Three or more years complex worldwide CMC regulatory strategies/requirements and demonstrated ability to influence the global internal/external regulatory environment. 
Two or more years of experience managing and directing multiple projects/teams in a high matrix environment.
One or more years of experience fulfilling a key role in major filing activities.
Experienced in supervising and training junior staff and the ability to motivate and lead others.
Managing the global CMC regulatory activities for multiple projects/teams simultaneously and respond readily to changing events and priorities.

Are you looking for an exciting opportunity to make a real difference in the healthcare industry? We are looking for a Regulatory Affairs Officer to join our team and help us ensure that our products meet all regulatory requirements. If you have a passion for regulatory compliance and a drive to make a positive impact, this could be the perfect job for you!

Overview: Regulatory Affairs Officers are responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They work closely with other departments such as research and development, marketing, and legal to ensure that products meet the necessary standards. They also provide advice and guidance on regulatory issues, and monitor changes in the regulatory environment. How to Become a Regulatory Affairs Officer: To become a Regulatory Affairs Officer, you must have a bachelor’s degree in a related field such as biology, chemistry, or engineering. You may also need to have experience in the field, such as working in a laboratory or in a regulatory agency. Regulatory Affairs Officer Skills: Regulatory Affairs Officers must have strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills. They must also be able to work independently and as part of a team. Regulatory Affairs Officer Knowledge: Regulatory Affairs Officers must have a thorough understanding of the laws and regulations that apply to their company’s products and services. They must also be familiar with the relevant industry standards and guidelines. Regulatory Affairs Officer Responsibilities: Regulatory Affairs Officers are responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They must also provide advice and guidance on regulatory issues, and monitor changes in the regulatory environment. Regulatory Affairs Officer Experience: Regulatory Affairs Officers must have experience in the field, such as working in a laboratory or in a regulatory agency. Regulatory Affairs Officer Qualifications: Regulatory Affairs Officers must have a bachelor’s degree in a related field such as biology, chemistry, or engineering. Regulatory Affairs Officer Education: Regulatory Affairs Officers must have a thorough understanding of the laws and regulations that apply to their company’s products and services. They must also be familiar with the relevant industry standards and guidelines. Tools to Help Regulatory Affairs Officer Work Better: Regulatory Affairs Officers can use software such as Microsoft Office, Adobe Acrobat, and other document management systems to help them manage their work. They can also use online databases to stay up-to-date on the latest regulations. Good Tips to Help Regulatory Affairs Officer Do More Effectively: Regulatory Affairs Officers should stay organized and keep detailed records of their work. They should also be proactive in researching new regulations and staying up-to-date on changes in the regulatory environment.

Common Regulatory Affairs Officer Interview Questions:

• What experience do you have in regulatory affairs?
• How do you stay up-to-date on changes in the regulatory environment?
• What challenges have you faced in regulatory affairs?
• How do you ensure that a company’s products and services comply with all applicable laws and regulations?
• What strategies do you use to ensure compliance?