Regulatory Affairs Associate

4 months ago

Vancouver, Canada Response Biomedical Full time

**Who we are**:
Response Biomedical Corp. has been transforming acute care diagnostic testing, with the central focus on improving patient outcomes and healthcare reform for over 20 years. Response Biomedical fosters a values-based culture, committed to making diversity and inclusion our way of doing business. We believe the people we work with including our partners, medical teams, and employees are the cornerstone of our success.

**What we do**:
Our RAMP platform is a global leader in diagnostic testing solutions for use in cardiovascular, infectious disease, sepsis, women’s health, arbovirus, and biodefense. We understand the stresses associated with rapid, accurate diagnosis when every minute counts, and are committed to collaborating with the teams that are dedicated to saving lives. We do this by providing lab-quality results within minutes that medical teams can trust, while reducing total cost of care.

**Who we are looking for**:
We are currently seeking for a dynamic Regulatory Affairs Associate who will be responsible to register and maintain regulatory approvals in the global markets that the RAMP products are sold in to support the core purpose of saving lives globally through providing tools that aid in diagnosis in acute care settings.

**Key Responsibilities**:
**Regulatory Affairs**
- Responsible for the planning, preparation and review of regulatory submissions within the assigned jurisdictions for new products, product changes and re-registrations and collaborates with their assigned regulatory representative.
- Ensures all the regulatory submissions for new products, product changes and re-registrations within the assigned jurisdictions are accurate and in compliance to the country specific regulatory requirements.
- Supports the monitoring, gathering, analyzing, and interpreting information related to Regulatory requirements, regulatory developments and changes, and trends that may impact the organization and RAMP® products.
- Supports the development, maintenance and review of procedures and processes directly linked to Regulatory and ensure compliance to global regulations and requirements of the of the QMS.
- Supports the review and maintenance of Risk Management files for all RAMP® products.
- Supports the review and creation of labelling materials and ensures compliance with applicable regulations and technical standards.
- Prepares, supports, and participates in quality and regulatory audits, assuring readiness.
- Supports the training initiatives specific to regulatory guidance to all staff on regulatory practices.
- Maintains and organizes appropriate regulatory documents and records to demonstrate compliance with applicable regulations and requirements.

**Post Market Surveillance**
- Supports the initiation, management and follow-up of regulatory filings, submissions, MDR’s and recalls under review.
- Supports the post market surveillance activities required by the regulatory bodies (US FDA, Health Canada, notified bodies, competent authorities, MHRA, etc.)

**Education, Work Experience, Knowledge, and Skills**:
**Formal Education**:
Minimum BSc in a scientific discipline

**Work Experience**:

- 2 - 4 years of experience in Regulatory Affairs or in a regulated industry
- Experience in a medical device manufacturing environment preferred.

**Skills and Knowledge**:

- Demonstrable detailed working knowledge of the medical device industry and the regulatory environment in which the business
- An analytical approach to problem
- A self-starter that applies their own initiative in most situations
- A good team player, who works well in a small team environment, must be able to work effectively with peers in other departments.
- A good communicator who can easily convey his/her standards and requirements across all levels in the organization and demonstrate confidence and presence in front of external regulatory body personnel.
- Displays the highest levels of integrity and a demonstrated ability to influence his/her peers.
- Attention to detail and ability to stay connected to multiple projects simultaneously.
- Knowledge of requirements in other jurisdictions where
- Knowledge of medical device quality standards/practices or similar regulated industry.
- We regret that relocation will not be provided._- We're committed to a diverse and inclusive workplace. We welcome applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. All employment decisions are based on business needs, job requirements and individual qualifications._

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