Regulatory Affairs Jobs

Intermediate project management, time management and organizational skills

4 -10 years’ related experience and/or training or equivalent combination of education and experience

Advanced knowledge of the electricity regulated industry or equivalent experience with emphasis on rate design and cost allocation methodologies

Intermediate knowledge of Occupational Health and Safety requirements as it relates to individual, organizational and operational requirements

Senior Manager of Regulatory Affairs and Risk Management.

8 years’ experience in a supervisory role

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

· 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.

Prepare and distribute regulatory updates to senor management and present key updates and developments to the Compliance Committee

At least 10 years of relevant experience in regulatory/fintech law.

Knowledge of applicable laws and regulations in the payment services industry.

Knowledge of gaming or data protection laws is an asset.

Experience working in a global public company is an asset.

Working knowledge of cryptocurrencies and alternative payment methods is a plus.

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.

A minimum of 5 years relevant clinical education experience, preferably in an academic health science centre

Leadership, mentorship, management and organizational

Inter-institutional relationship management and nurturance

Human resource management in both unionized and non-unionized environments

Budgetary management, forecasting, tracking and course correction

Change identification, implementation and management

•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