Senior Regulatory Affairs Specialist 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

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.

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.

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.

Knowledge of submission requirements and timelines

Collaborate with global and local teams to manage critical timelines.

Post-secondary degree or relevant work experience

3-5 years of experience pharmaceutical/OTC industry experience in Regulatory Affairs

3-5 years of experience with submissions and negotiations with Health Canada

3-5 years of experience in OTC or Consumer Healthcare

Superior organization and time management.

Strong interpersonal & excellent communication skills (verbal & written) and follow through abilities

3-5 years of experience in Technical Services or Regulatory role with a North American food company.

· Manage regulatory customer inquiries related to all products; keep Business/Customer Development Mangers up-to-date with customer communications.

· Complete all other duties as assigned by Supervisor/Manager

Science Degree or Diploma (preference for Food Science/Regulatory Affairs Specialization).

Adhere to requirements of the Quality Management System.

Working knowledge of relevant EU regulatory requirements for medical devices including Quality Systems standards

A minimum of a bachelor's degree or equivalent work experience

Previous experience with EU MDR notified body reviews for Class III devices

Experience working directly with notified bodies is desired

Coordinates, compiles, and submits CE Mark submissions under the EU MDR

Knowledge of the requirements of an ISO 13485 quality program

Experience using database software to manage data and records is an asset.

Maintain current body of knowledge on regulations and standards that may impact regulatory approvals for products currently being marketed

Certificate in Regulatory Affairs or equivalent work experience

1-2 years of regulatory experience in a medical device environment within Health Canada

Knowledge and understanding of regulations governing medical devices in Canada, US and Europe is an asset

Be a valuable member of our risk management team, contributing from a regulatory perspective to risk assessment exercises and documents

Build partnerships, internally and externally, to provide routine updates and ensure compliance with regulatory requirements

A minimum of 3 years of experience in regulatory affairs within the medical device or life sciences industry

Proven experience in compiling and submitting pre-market regulatory submissions, such as 510(k), De novo, and IVDR Technical Documentation

Collaborate with cross-functional teams to provide regulatory inputs during the design and development phase of our devices

Compile pre-market submissions, including pre-submissions, 510(k), De novo, and IVDR Technical Documentation as necessary

Self-motivated with organizational and time management skills

We offer a competitive salary, bonus structure and a comprehensive benefits package.

Excellent communication skills; both verbal and written. Fluency in Spanish or French will be an asset.

1-2 years of experience in registration would be an asset.

·Oversee all projects related to fertilizer product labels to ensure compliance requirements

University Degree in Science, Agriculture or Regulatory field

Support maintenance of Diva’s ISO 13485 certification and Quality Management System as a whole.

Experience in the maintenance of Quality Management Systems, e.g., ISO 13485 and FDA QSR for medical devices;

Report on performance of the QMS to top management

Proficient in MS Office applications, quality management software & tools, and the ability to learn new software as required;

Prepare, upkeep and manage FDA, Health Canada, and other worldwide regulatory submissions as well as other regulatory related documents;

Ensure compliance with applicable regulatory standards/requirements;

Perform additional duties as assigned by Management

Bachelor’s degree with relevant experience in the pharmaceutical industry

Minimum of three (3) to five (5) years of relevant experience in the pharmaceutical industry.

Detail-oriented, reliable, autonomy and judgment capacity toward the application of regulatory requirements.

Excellent organization and planning skills

Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration.

Participate in cross-functional teams to support product development, regulatory strategy, and risk management activities.

In-depth knowledge of global regulatory requirements and guidelines pertaining to clinical trials and CMC aspects.

Familiarity with regulatory software and document management systems is a plus.

Review and approve manufacturing and analytical documentation, including batch records, specifications, and stability protocols/reports, to ensure compliance with regulatory requirements.

Experience in preparing and submitting regulatory filings (e.g., INDs, CTAs, IMPDs, MAAs).

Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to cross-functional teams.

Maintain current knowledge of HC, FDA, and other international regulations and documentation requirements.

A minimum of 2 years of relevant work experience, not including internships

Experience in the Beauty industry / CPG Industry is a strong asset

Excellent organizational skills, dependable, able to multi-task and meet multiple deadlines

Strong interpersonal skills and ability to communicate (verbal and written) effectively

Basic knowledge of US, Canada, US/UK cosmetic regulatory environment.

Proficiency with Microsoft Excel and general computer skills

hybrid work schedule with some on-site office and remote work

Ideal candidate background: previous regulatory affairs experience is preferred, especially experience with Medical devices

Job Title: Regulatory Affairs Specialist

Job Location: Markham, ON (Hybrid)

Job Duration: Until Aug 2024

Report trends from product feedback to support continuous improvement, vigilance activities and management reviews

Knowledge of the requirements of an ISO 13485 quality program

Experience using database software to manage data and records is an asset.

Maintain current body of knowledge on regulations and standards that may impact regulatory approvals for products currently being marketed

Certificate in Regulatory Affairs or equivalent work experience

Minimum of 5 years of regulatory experience in a medical device environment

Project management skills with a demonstrated ability to write detailed technical reports;

Evaluating Request for Proposals and prepare responses, develop work scopes, budgets and schedules, and providing project management;

Willingness to occasionally travel, including to remote locations and outside standard office hours;

Managing projects related to renewable energy, transportation, industrial development, infrastructure, mining and oil and gas sectors;

Managing projects and our clients simultaneously while fostering a collaborative and inclusive team environment;

Acting as a mentor for junior staff and collaborate regionally and nationally with other EIA practitioners;

Ideal candidate background: previous regulatory affairs experience is preferred, especially experience with Medical device

Proficiency with Microsoft Excel and general computer skills

hybrid work schedule with some on-site office and remote work

Job Title: Regulatory Affairs Specialist 2

Location: Markham / Ontario / Canada L3R 0T5 - Hybird

Excellent communication and comprehension of the English language