Regulatory Affairs Specialist

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