Career Opportunity: RA Specialist
File No: RA-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
- Prepare complex submissions including change notifications, amendments and initial
applications to US FDA (PMA supplements, 510(k)s, new PMAs), Health Canada (MDL), EC
Notified Body/ Competent Authority, WHO, and dossier submissions to other regulatory
- Familiar to IVD classification and accomplish IVD III/IV registration project independently.
- Able to explain medical devices related regulations, policies, or submission procedures
- Evaluate applicable laws and regulations to determine impact on company activities
- Provide technical review of data or reports
- Coordinate regulatory documentation activities
- Identify and interpret relevant regulatory guidelines
- Complete Junior Specialist and Associate tasks when employees are away or positions are
- Provide routine project updates
- Support regulatory activities related to product registrations in rest-of-the-world markets
including but not limited to countries in Asia, Africa and Latin America
- Browse FDA/WHO/EU/Health Canada website regularly, keep all the regulation/ requirements/
guidelines etc. updated, and share those newest information / regulation with RA team
- Provide existed documents for sales team
REQUIREMENTS AND SKILLS:
- At least bachelor’s degree in life science relevant study fields.
- 3+ years of direct experience in medical devices registration and biotech regulatory affairs.
- Experience applying for 510(k)s, WHO/ Health Canada/EU etc. registration.
- Can be trusted by Regulatory Affairs (RA) management as an independent regulatory core team
lead on project teams.
- Willingness in collaboration and learning
- Multitasking and self-directed skills are required
- Ability to supervise other RA employees by providing basic guideline
- Ability to meet tight deadline and submit regulatory files with accuracy
- Willingness to take extra effort to complete job tasks
- Awareness of keep tracking on the ongoing projects and report to the RA manager
- Master’s degree in life science relevant study fields.
- 5+ years of direct experience in medical devices registration and biotech regulatory affairs.
- Experience in working with US FDA and other regulatory agencies is preferred.
- Experienced in Regulatory Affairs who can drive and advance regulatory efforts for launching
Artron’s products in the target market.
- Ability to communicate in verbal and written Mandarin
- Regulatory Affair: 3 years (required)
- Dental care
- Extended health care
- Vision care
- 8-hour shift
- Monday to Friday