Regulatory Affairs Manager

2 weeks 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 Affaires and Quality Assurance 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 free holiday gifts, etc.

**Responsibilities**:
RA Manager manages all aspects related to Quality Assurance and Regulatory Affairs. The manager ensures the full functionality in its entirety of the respective departments. Some specific duties include but are not limited to the following:

- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.
- Establish protocols to ensure company meets the requirements of different regulatory bodies, licensing agencies, etc.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Oversee QA and RA activities and ensures all quality systems are operating effectively.
- Make recommendations for improvements in products or processes.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Collaborate with R&D and production department teams to develop strategies, to maintain consistency with business and R&D goals for successful product registration.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Investigate product complaints and prepares documentation and submissions to appropriate regulatory agencies as necessary.
- Supervise RA specialist and RA assistant for completing the daily job tasks and the particular projects.

**Education and Experience**:

- A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline.
- 8+ years of professional experience in regulatory affairs and quality assurance relating to in vitro diagnostic medical devices.

**Qualifications**:

- Extensive knowledge and experiences in IVD industry.
- Extensive knowledge and experiences in EU/Health Canada/FDA/WHO IVD registration.
- Extensive knowledge of Regulation(EU) 2017/746
- Able to work well in cross-functional teams, independent yet a team player.
- Must have good visual awareness, computer skills, written/ oral communication skills and knowledge on global product submission requirements.
- Experienced in leading cross-functional interactions related to regulatory matters.
- Leadership experience in conflict management, constructive feedback, mentoring and motivating department employees.

**Preferred**:

- Experience in working with EU/ Health Canada and other regulatory agencies is preferred.
- Experienced Regulatory Affairs manager who can drive and advance regulatory efforts for launching Artron’s products in the target market.
- Fluent Mandarin speaking

**Salary**: $80,000.00-$120,000.00 per year

**Benefits**:

- Casual dress
- Company events
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Vision care

Schedule:

- 8 hour shift
- Monday to Friday

**Experience**:

- RA Manager: 3 years (required)

Work Location: In person

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