Regulatory Affairs Specialist

2 weeks 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 a dynamic Regulatory Affairs Specialist to assist in the running of the regulatory affairs by providing input into regulatory strategies, performing activities associated with obtaining and maintaining regulatory approval to commercialize medical devices in selected target markets, and providing regulatory affairs input for the functional areas.

We are looking for someone who has a thorough understanding of the regulatory requirements required for the Medical Device Industry within global jurisdictions.

**Key Responsibilities**:

- Assist in the running of the regulatory affairs programs in accordance with internal procedures and regulatory requirements.
- Plan and prepare regulatory submissions for specific target markets for new products, product changes and re-registrations as needed or collaborates with their assigned regulatory specialists on same.
- Review submissions generated for their assigned regulatory area to ensure compliance to the regulations in that particular jurisdiction.
- Act as/on behalf of “Person Responsible for Regulatory Compliance” (Regulatory Representative) as required by global and/or local regulatory requirements.
- Provide input to Global and local RA strategies. Assess potential risks and provide input for product development plans.
- Provide regulatory input into product design control requirements and participate in design reviews. Support project teams to ensure adherence to these requirements for all stages of new product development.
- Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
- Initiation, management and follow-up of regulatory filings, submissions, MDR’s and recalls under review.
- Responsible for the preparation, compilation & assembly of re-submission documents to government agencies, for both Response and on behalf of customers.

**Education, Work Experience, Knowledge, and Skills**:
**Formal Education**:

- Third level Qualification preferably in Science/Quality. A minimum of 3 years of relevant regulatory affairs experience, or equivalent combination of post-graduate education and experience

**Work Experience**:

- Demonstrable detailed working knowledge of the medical device industry and the regulatory environment in which the business operates.
- Experience with Class II/III medical devices, IVDs, or pharmaceuticals
- In-depth working knowledge of European, US, and Canadian medical device regulatory requirements is an asset

**Skills and Knowledge**:

- Demonstrable detailed working knowledge of the medical device industry and the regulatory environment in which the business operates.
- An analytical approach to problem solving.
- 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 required.
- Knowledge of medical device quality standards/practices or similar regulated industry.
- Good communication

Other Requirements
- Must be legally eligible to work in Canada.
- Must live in Canada, preferably in British Columbia, and be willing to move to Vancouver area.
- _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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