Regulatory Affairs Specialist

Department: Operations

Reports To: Director of Clinic Operations

Location: Vancouver

Work Schedule: 7.5 hours per day/37.5 hours per week (weekends as needed)

Overview:

Supporting the Vision, Values, Purpose, and Commitment of Olive Fertility Centre:

Reporting to the Director of Clinic Operations, the Regulatory Affairs Specialist is pivotal to the organization – this role focuses on leading the accreditation process for all clinic locations and managing all College of Physicians and Surgeons of British Columbia (CPSBC) Non-Hospital Medical and Surgical Facilities Accreditation Program and Standards. This role ensures policies and protocols support regulated staff to practice within their scope, leading the Health and Safety Committee and initiatives, and supporting specialized programs’ accreditations (Novavita – Diagnostic Accreditation Program; 3rd Party – Health Canada Safety of Sperm and Ova Regulation Inspections).

Key Areas of Involvement Include:

Regulatory

· Collaborate and coordinate with the medical and laboratory directors to ensure the clinic is compliant with relevant regulatory bodies.

· Assess and advise on improvements to compliance with relevant regulatory bodies, such as:

o College of Physicians and Surgeons of BC,

o BC College of Nurses and Midwives,

o Ministry of Health (MSC/MSP),

o WorkSafe BC,

o Other provincial and federal regulations (privacy), and

o Other clinical specialities of personnel we employ.

· Identify and interpret relevant regulatory guidelines.

· Evaluate applicable regulations to determine impact on company policies, procedures, and infrastructure, ensuring Olive Fertility Centre’s standards of practice meet or exceed regulatory standards.

· Facilitate conversations and improvements related to regulatory compliance.

· Attend and participate in all quality management and risk management meetings:

o Provide guidance from an accreditation perspective to leaders.

o Make recommendations for process improvements with a regulatory focus.

o Track all critical incidents and near misses and identify if clinical incidents stem from policy/procedure, advise on how to address these issues at the root of the problem.

· Work in close partnership with the Clinic Management Team to ensure that optimal patient care and standards of practice are always maintained.

· Act as the internal process improvement facilitator, providing a structured way of evaluating current practices and goals, and guiding a team through the process.

· Coordinate with appropriate leaders and educators to maintain all clinical procedures and training program documents and sign off records.

· Manage all physician privileges and documentation

· Licensures and certifications: ensure professional staff (physicians, nurses, etc.) provide documentation of current licensure.

Accreditation

· Standard Operating Procedure (SOP) Document management – compile, update, maintain and manage creation of clinical SOPs.

· Prior to an accreditation or inspection, coordinate the gathering of all necessary documents, forms, and any other applicable paperwork in collaboration with managers and the clinical leaders.

· Maintain all documentation related to accreditation and coordinate the reporting for CPSBC Accreditation, including submission of documentation and responses to the CPSBC.

o Oversee and collaborate to ensure documentation of current licencing and certifications of registered staff required by the CPSBC.

· Advise and guide document management systems to maintain compliance with accreditation standards (standard operating procedures and forms).

· Utilize and enhance standardized process of SOP creation and maintenance.

· Receive, consolidate, and assess suggestions from staff for practices they hope to standardize.

o Create and maintain the annual evaluation schedule, batching similar and related SOPs for evaluation and clinic-wide education.

o Collaborating with necessary leaders and departments.

· Participate/perform reporting to CPSBC as required.

o Initial privileging of physicians

o Annual procedural statistics

Privacy

· Serve as the clinic Privacy Officer

· Act as the first point of contract for patient privacy issues

· Develop, implement, and maintain a patient privacy policy.

· Develop and implement privacy training for all patient-facing employees.

· Ensure patient information is kept private and confidential.

· Work in accordance with the practices Health and Safety Policies & Procedures and in compliance with applicable provincial legislation.

Health and Safety

· Act as the Employer Representative Co-Chair for a term of 2 years, after which act as the Joint Health and Safety Committee Facilitator

· Review previous meeting reports.

· Prepare the meeting agenda and ensure members are informed of upcoming meetings.

· Keep meeting discussions on track.

· Communicate on behalf of committee (i.e. Prepare correspondence and committee recommendations).

· Provide meeting minutes to the employer.

· Conduct or provide input on the annual evaluation of the joint committee.

· Coach and advise committee members.

· Any other amendments to responsibilities as released by WorkSafe BC in the future.

Qualifications:

Education, Training and Experience:

· Bachelor’s Degree or Diploma in health science or business or a related field, with a minimum of two years of Regulatory or Quality experience in a regulated industry

· Experience with Non-Hospital Medical and Surgical Facilities Accreditation Program and Standards

· Experience with process improvement methodologies (Ex. LEAN, Six Sigma, or other).

· Intermediate to advanced computer skills including knowledge of Microsoft Office (Word, Excel, Outlook, and PowerPoint, in particular) and databases. Understanding of the internet is necessary.

· Previous experience in reproductive endocrinology (fertility) is not required but is an asset.

Key Skills and Abilities:

· Detail-oriented in all areas of responsibility.

· Communicate effectively verbally and in writing.

· Develop relationships and rapport with clinic leadership and external stakeholders.

· Demonstrate ability to problem-solve, reason, and exercise critical thinking skills.

· Manage time appropriately to achieve deadlines.

· Able to work independently and as part of a team.

· Organization of tasks

· Experience with document management

· Able to interpret and apply regulatory language.

· Strong organizational understanding.

Job Types: Full-time, Permanent

Salary: From $80,000.00 per year

Benefits:

Company events

Dental care

Disability insurance

Employee assistance program

Extended health care

Life insurance

Paid time off

RRSP match

Tuition reimbursement

Vision care

Wellness program

Schedule:

8 hour shift

Day shift

Monday to Friday

Education:

AEC / DEP or Skilled Trade Certificate (required)

Experience:

Regulatory or Quality: 2 years (required)

Ability to Commute:

Vancouver, BC (required)

Work Location: In person