Regulatory Affairs Associate

at  Response Biomedical

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.

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.
  The starting salary for this position ranges from $48,000 to $51,000 annually, depending on the candidate’s experience and qualifications. Our salary structure is aligned with market standards and is finalized considering factors such as job-related expertise, skills, education, and experience.

Please note that this position is only available to candidates who are authorized to work in Canada.

• We regret that relocation will not be provided.
• While we appreciate the interest of all applicants, only those candidates selected for interview will be contacted.

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.