Regulatory Compliance & Enforcement Specialist

Important messages

We are committed to providing an inclusive and barrier-free work environment, starting with the hiring process. If you need to be accommodated during any phase of the evaluation process, please use the Contact information below to request specialized accommodation. All information received in relation to accommodation will be kept confidential.

Assessment accommodation

You must meet all essential qualifications in order to be appointed to the position. Other qualifications may be a deciding factor in choosing the person to be appointed. Some essential and other qualifications will be assessed through your application. It is your responsibility to provide appropriate examples that illustrate how you meet each qualification. Failing to do so could result in your application being rejected.

Work environment

At Health Canada (HC), you can be part of a dynamic and multi-disciplinary team of individuals who help protect the health and safety of Canadians. Health Canada plays an active role in ensuring that you have access to safe and effective health products. The Department strives to maintain a balance between the potential health benefits and risks posed by health products. Our highest priority in determining the balance is public safety.

We are currently looking for compliance specialists to join our team. If you have been working in the medical device industry and have considerable experience in regulatory affairs, the quality assurance and/or quality control of Medical Devices, join our team now as either a Corporate or Regional Regulatory Compliance and Enforcement Specialist. We are also recruiting Regional Regulatory Compliance and Enforcement Specialists to work in our Border Operations Centres, where you will work with the Canadian Border Services Agency and your colleagues across the country to protect Canadians from unauthorized importations of health products.

Stream 1: Medical Devices
Stream 2: Border Operations

We are proud of our growing national team and team spirit, and we provide opportunities to collaborate, learn and grow. Health Canada encourages a work-life balance. Teleworking, compressed work hours, and a valuable pension plan are some of the many possibilities and benefits of being a public servant.

What better time than now to work for HC and contribute to the protection of all Canadians. Come join us!

Intent of the process

This is an anticipatory process. A pool of qualified candidates will be established to fill similar positions with various tenures (temporary, permanent) across Canada, within the Medical Devices and Clinical Compliance Directorate. The pool could also be used for acting appointments should the candidate already be a public servant.

Positions to be filled: Number to be determined

Information you must provide

Your résumé.

In order to be considered, your application must clearly explain how you meet the following (essential qualifications)

Graduation with a degree from a recognized post-secondary institution with acceptable specialization in microbiology, chemistry, mechanical engineering, pharmacy, food science, or some other specialty related to the position.

Degree equivalency

Experience (both streams):

Significant** experience leading or contributing to the development of policy OR guidance OR procedures related to regulated health products

The following will be applied / assessed at a later date (essential for the job)

Various language requirements
English Essential
Bilingual - Imperative (BBB/BBB)

Information on language requirements

Stream 1

1) Significant** work experience in one or more of the following areas within the medical device industry:
• production
• regulatory affairs
• quality assurance
• quality control
• auditing
OR
Recent* and significant** experience in the execution of compliance and enforcement activities under the Food and Drugs Act within an Agency or Department of the Government of Canada.

Stream 2

1) Significant** experience interpreting and applying regulatory requirements in the context of importation of goods into Canada.

2) Recent* experience in preparing and delivering presentations to internal or external stakeholders.

3) Significant** experience responding to inquiries from internal and external stakeholders.

Definitions:
*Recent is generally defined as within the last five (5) years.
**Significant is generally defined as two (2) years.

Knowledge (both streams):
Knowledge of Canadian legislation and policies regarding health products and compliance and enforcement.

Knowledge Stream 1:
Knowledge of the Regulatory Framework for Medical Devices in Canada

Knowledge Stream 2:
Knowledge of the Regulatory Frameworks for Health Products in Canada, with respect to importation requirements.

Competencies (both streams):

Interpersonal Relations
Judgement
Teamwork
Focus on Service
Commitment and Ethics
Respectful of Diversity
Oral and Written Communication

Abilities (both streams):

Ability to analyse complex issues and recommend viable solutions.
Ability to provide technical advice and guidance.

The following may be applied / assessed at a later date (may be needed for the job)

Asset Education:
Graduate studies diploma from a recognized post-secondary institution, in the area of regulatory affairs for health products.

Degree equivalency

Asset Experience:

Experience in developing or leading activities in order to implement or maintain a Quality Management System (eg: ISO 9001, or ISO 13485)

Experience planning, leading or coordinating inspections, audits or compliance verifications against regulatory requirements.

Experience assessing compliance with Federal Acts and regulations

Experience conducting enforcement activities under the Food and Drugs Act and Regulations, either within Health Canada, or within industry (eg: recalls, risk communications, etc.).

Experience developing and delivering technical training.

Experience in project management.

Experience providing recommendations of admissibility, to the Canadian Border Services Agency.

Conditions of employment

Reliability Status security clearance

Possession a valid driver’s licence
Willingness to travel within and outside Canada
Willingness to work overtime evenings and weekends occasionally

Other information

The Public Service of Canada is committed to building a skilled and diverse workforce that reflects the Canadians we serve. We promote employment equity and encourage you to indicate if you belong to one of the designated groups when you apply.

Information on employment equity

Persons with disabilities preventing them from applying on-line are asked to contact 1-800-645-5605.

Please ensure that your email address is on your application for correspondence. Communication for this process will be sent via email. It is the responsibility of the candidate to ensure accurate contact information is provided and updated as required. Candidates who apply to this selection process should include an email address that accepts email from unknown users (some email systems block these types of email.)

Persons are entitled to participate in the appointment process in the official language of their choice. Applicants are asked to indicate their preferred official language in their application.

Once the candidates have been assessed and the pool is created, it will not be possible for the candidates in this pool to add additional information regarding merit criteria for future consideration, except for linguistic results. Also, no additional candidates will be added to the pool for all of its duration.

Candidates who have been fully assessed and found to have met all essential qualifications except official language requirements may update their second-language evaluation (SLE) results for as long as the pool is/pools are valid. N.B.: Each candidate can only undergo SLE testing one time within the context of an appointment process; any update to a candidate's linguistic profile must be as a result of subsequent SLE testing done outside of this appointment process.

The Public Service of Canada is committed to building a skilled, diverse workforce reflective of Canadian society. As a result, it promotes employment equity and encourages candidates to indicate voluntarily on their application if they are a woman, an Aboriginal person, a person with a disability or a member of a visible minority group.

The Public Service of Canada is also committed to developing inclusive, barrier-free selection processes and work environments. If contacted in relation to a job opportunity or testing, you should advise the Public Service Commission or the departmental official in a timely fashion of the accommodation measures which must be taken to enable you to be assessed in a fair and equitable manner. Information received relating to accommodation measures will be addressed confidentially.

Preference

Preference will be given to veterans and to Canadian citizens, in that order, with the exception of a job located in Nunavut, where Nunavut Inuit will be appointed first.

Information on the preference to veterans

We thank all those who apply. Only those selected for further consideration will be contacted.