Regulatory Affairs Specialist

5 months ago

Burnaby, Canada Artron Laboratories Inc. Full time

Artron Laboratories Inc is a technology-based manufacturer specialized in the development and large-scale production of lateral flow rapid test kits. Artron established itself in the progression of in vitro diagnostic lateral flow tests that have revolutionized the market for disease diagnosis and analyte detection. At Artron, we are committed to going above and beyond to meet the specific challenges faced by the rapid diagnostic industry participants. Our mission is to overcome industry challenges and provide simple and affordable IVD products that meet customer’s highest expectations.

We are looking for highly organized individual dedicated to regulatory affair to join our team At Artron, we offer competitive salary and benefits package, dental and vision extended health insurance, friendly working environment, year end bonus, and holiday gifts.

**Responsibilities**:

- **Regulatory Strategy and Compliance**: Developing and maintaining regulatory strategies that align with company objectives, ensuring that all aspects of product development, manufacturing, and marketing in compliance with regulatory requirements.
- **Product Registration and Approval**: Overseeing the preparation and submission of documents required for registering and gaining approval for devices from US FDA, Health Canada, EC Notified Body/ Competent Authority, WHO and other countries’ regulatory authorities.
- **Documentation and Record Keeping**: Ensuring that all product documentation, including labeling, instructions for use, and marketing materials, are accurate and comply with regulatory standards, and the technical documentation and declaration of conformity are drawn up and kept up to date. Maintaining comprehensive records of all regulatory correspondence, submissions, and approvals.
- **Post-Market Surveillance**: Monitoring the performance of the devices after they have been launched in the market. This includes managing recalls or safety alerts if necessary and ensuring that any adverse events or malfunctions are reported to regulatory authorities in a timely manner.
- **Staying Informed**: Keeping up to date with changes in regulatory requirements and industry standards, both at a national and international level, and assessing the impact of these changes on the company's operations and product portfolio.
- **Cross-Functional Collaboration**: Working closely with other departments such as Research and Development, Quality Assurance, Manufacturing, and Marketing to ensure a cohesive approach to regulatory compliance throughout the product lifecycle.

**Education and Experience**:

- At least bachelor’s degree in medicine, pharmacy, engineering, or another relevant life science (Biology, chemistry or biochemistry) study fields.
- 4+ years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.

**Skills**:

- Regulatory Knowledge: Thorough understanding of the regulatory guidelines and standards (such as FDA, EMA, ISO 13485, and the IVDR in Europe) that govern the development, testing, approval, and post-market surveillance of in vitro diagnostic medical devices.
- Attention to Detail: Ability to manage complex documentation and ensure accuracy and compliance in all regulatory submissions.
- Communication Skills: Strong written and verbal communication skills are crucial for preparing regulatory documentation, interacting with regulatory authorities, and collaborating with cross-functional teams.
- Analytical Skills: Ability to analyze scientific and clinical data to ensure regulatory compliance and support product approvals.
- Project Management: Skills to manage multiple projects and timelines efficiently, ensuring that regulatory submissions are made in a timely manner and product launches are not delayed.
- Problem-Solving: Ability to navigate and resolve regulatory issues that may arise during the product development lifecycle, including strategy development for regulatory compliance.
- Teamwork and Collaboration: Ability to work effectively with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Marketing, to ensure that all aspects of product development and launch align with regulatory requirements.
- Continual Learning: Commitment to staying updated with the ever-changing regulatory landscape, including new laws, regulations, and guidelines relevant to in vitro diagnostic medical devices.

**Preferred**:

- Ability to communicate in verbal and written Mandarin

**Salary**: $65,000.00-$100,000.00 per year

**Benefits**:

- Dental care
- Extended health care
- Paid time off
- Vision care

Schedule:

- 8 hour shift
- Monday to Friday

**Education**:

- Bachelor's Degree (required)

**Experience**:

- Regulatory Affair: 4 years (required)

Work Location: In person

  • Regulatory Affairs Manager

    6 months ago

    Burnaby, Canada Artron Laboratories Inc. Full time

    Artron Laboratories Inc is a technology-based manufacturer specialized in the development and large-scale production of lateral flow rapid test kits. Artron established itself in the progression of in vitro diagnostic lateral flow tests that have revolutionized the market for disease diagnosis and analyte detection. At Artron, we are committed to going above...

  • Regulatory Affairs Specialist

    2 months ago

    Burnaby, Canada Kardium Inc. Full time

    Your opportunity By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation - which can cause stroke, heart failure, and other heart-related complications. Kardium’s...

  • Regulatory Affairs Coordinator

    6 months ago

    Burnaby, Canada Daiya Foods Inc. Full time

    Welcome to the unexpected delight of plant-based exploration! We're the creators of a revolutionary cheese alternative that tastes, shreds, melts and stretches like traditional cheese. Today, as plant-based food grows in popularity, that spirit of innovation continues to inspire our team. We believe in pioneering plant-based breakthroughs that delight...

  • Project Manager, Regulatory Affairs

    6 months ago

    Burnaby, Canada Kardium Full time

    **Your opportunity** By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a ground breaking medical device for the mínimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications. Kardium...

  • Regulatory Compliance Specialist

    4 weeks ago

    Burnaby, British Columbia, Canada BC Hydro] Full time

    Job OverviewAt BC Hydro, we are seeking a skilled Regulatory Compliance Specialist to join our team. This role is responsible for ensuring compliance with regulatory requirements and industry standards.Key ResponsibilitiesDevelop and implement regulatory compliance programs.Conduct regulatory research and analysis.Collaborate with cross-functional teams to...

  • Regulatory Manager

    2 months ago

    Burnaby, Canada Sunco Foods Inc Full time

    **Job Summary**: **Key Responsibilities**: - Establish and lead a process of identifying, tracking and influencing proposed and pending regulatory changes potentially impacting Sunco Foods supply chains and finished good products - Identify proposed and pending SFCR and FDA regulatory changes impacting food service and retail products labels and supply...

  • Community Outreach Specialist, Public Affairs

    2 weeks ago

    Burnaby, British Columbia, Canada BC Housing Full time

    Job SummaryWe are seeking a highly skilled Community Outreach Specialist, Public Affairs to join our team at BC Housing. As a key member of our organization, you will be responsible for developing and implementing effective communication strategies to engage with our communities and tenants.

  • Document Control Specialist

    5 months ago

    Burnaby, Canada Kardium Full time

    **Your opportunity** By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the mínimally invasive diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation. Atrial fibrillation can cause stroke, heart failure, and other...

  • Quality Assurance Specialist

    6 months ago

    Burnaby, Canada Canda Six Fortune Enterprise Full time

    **Title** - Quality Assurance Specialist **Categories** - Permanent, Full-time **Location** - Burnaby, BC **Job Information** Canda Six Fortune Enterprise Co. Ltd. is one of the leading importers and distributors of Asian food products from the Pacific Rim and other regions of the world. We are currently looking for a team-player to help us promote high...

  • Quality Assurance Specialist

    6 months ago

    Burnaby, Canada Cardinal Health Full time

    Cardinal Health, with over 1300 employees in Canada, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country. Cardinal Health is seeking a positive individual to join the Regulatory Affairs and Quality Assurance team as a Quality Assurance...

  • Human Factors Team Lead

    5 months ago

    Burnaby, Canada Kardium Full time

    **Your opportunity** By joining the Kardium team, you can help make a difference in the lives of millions around the world. We are developing a ground-breaking medical device for mínimally invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications. Kardium has a...

  • Policy, Research and Community Affairs

    2 months ago

    Burnaby, Canada Simon Fraser Student Society Full time

    The Simon Fraser Student Society (SFSS) is a not-for-profit organization that represents all Undergraduate Students at the Simon Fraser University (SFU). The SFSS provides our members with a broad range of advocacy work, services, and events. The vision of the SFSS is for students to thrive everywhere and is realized through our support of students to reach...

  • Senior Communications Specialist, Community

    2 months ago

    Burnaby, Canada BC Housing Full time

    POSITION SUMMARY The Senior Communications Specialist, Community and Tenant Affairs is responsible for developing and implementing a wide range of strategies to inform and engage our communities and tenants in support of BC Housing’s corporate priorities. He/she/they develop and implement communications and engagement strategies for major new...

  • Regulatory Compliance Specialist

    4 weeks ago

    Burnaby, British Columbia, Canada BC Housing Full time

    Position OverviewThe Licensing Education and Training Coordinator, reporting to the Deputy Registrar, Licensing, is responsible for administering Licensing & Consumer Services' Continuing Professional Development (CPD) program for builders.Key ResponsibilitiesAssess and recommend approval for complex applications for new builder licences, builder licence...

  • Communications Specialist, Community

    5 months ago

    Burnaby, Canada BC Housing Full time

    **Position Summary**: **COMMUNICATIONS SPECIALIST, COMMUNITY & TENANT AFFAIRS (2 POSITIONS)** **Job ID: 5584** **FULL-TIME** **LOCATION: BURNABY, B.C** - ** Join one of BC’s Top Employers!**: - ** Be part of an exceptional company culture with great employee benefits and a healthy work/life balance!** **BC Housing thanks all applicants for their...

  • IT Support Specialist

    6 months ago

    Burnaby, Canada Kardium Full time

    **Your opportunity** By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the mínimally invasive diagnosis and treatment of the most common heart rhythm disorder, atrial fibrillation. Atrial fibrillation can cause stroke, heart failure, and other...

  • Power Engineer Specialist

    2 weeks ago

    Burnaby, British Columbia, Canada British Columbia Institute of Technology Full time

    Job OverviewWe are seeking a highly skilled Power Engineer Specialist to join our team at the British Columbia Institute of Technology. This is a regular, full-time position responsible for inventory control, maintenance of training aids, repair of specialized equipment, and the setup and demonstration of shop equipment or instructional aids in support of...

  • Environmental Health and Safety Specialist

    5 months ago

    Burnaby, Canada Kardium Full time

    **Environmental Health and Safety Specialist** **Your opportunity** By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a ground breaking medical device for the mínimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure,...

  • Community Life Specialist

    6 months ago

    Burnaby, Canada Simon Fraser University Full time

    Union/Affiliation: **Administrative and Professional Staff (APSA)** - Pay range: **$67,089 to $80,019 annually** - SFU Department Descr: **Student Services - Residences** - Position Grade: **7** - # of openings: **1** - Biweekly Hours: **72** **Who We Are** Residence and Housing is an integral part of SFU’s academic and educational programs and services....

  • Pharmacy Operations Specialist

    2 weeks ago

    Burnaby, British Columbia, Canada Save-On-Foods Full time

    About the RoleWe are seeking a highly skilled and experienced Pharmacy Operations Specialist to join our team at Script Care Pharmacy in Burnaby, BC.Job DescriptionThe successful candidate will be responsible for supporting day-to-day pharmacy central fill tasks, including:Preparing, packaging, dispensing, distribution, and storage of drugs and...