Regulatory Affairs Specialist

Company: LIGHT-MED USA INC.

Job Title: REGULATORY AFFAIRS SPECIALIST

Reports to: MANAGING DIRECTOR / R&D DIRECTOR

Company Overview:

LightMed USA Inc. is a medical devices company focused on development, manufacture and marketing of innovative and versatile lasers and diagnostic devices for the Ophthalmic, Dental and Dermatology market segments.

LightMed’s business philosophy is to commit to improving quality of life by providing physicians industry’s best value medical devices, blending innovative technologies with ergonomic devices at unbeatable cost.

LightMed Corp was founded in 1993 and is currently offering technologies and services in over 80 countries through global distribution network and direct subsidiaries in USA, Japan, China, Korea and Taiwan.

From 2015 LightMed is establishing its Manufacturing and Development operations in USA (San Clemente, CA) and we are looking for numerous professionals to join our growing team with prospects of enduring and rewarding career opportunities.

LightMed USA Inc. provides a relaxed and competent work environment with progressive advancement opportunities and international travel experience.

Job Objective:

We are looking for an Electrical Engineer with one to two years of experience, interested in learning to become a Regulatory Affairs Specialist for our medical products. You will be provided the proper training and guidance that will allow you to be responsible for regulatory affairs, quality management systems, and document control for our company.

Job Description:

The RA Specialist will be responsible for the overall FDA requirements. As we adapt new products and technologies, the RA Specialist is required to meet regulatory requirements in the global market for registration of LIGHTMED products. This position requires working closely with the R&D Engineers, Consultants, Sales, and Marketing team.

Regulatory Affairs

Establish and maintain compliance with FDA QSR(s) (GMP) including company registration, new product submissions, establishing FDA communication/channels, EU Market MDD 93/42/EEC directive Including CE mark or self-declaration. Learn to write a 510k submission. We will provide the necessary training to write regulatory reports. Work closely with accreditation Labs and be the point of contact for all regulatory communications within the company including responsible for incident reports, audits, and registrations, etc.

Participate in research of regulatory issues and disseminate regulatory information to other departments.

Ensure Compliance of labelling and advertising

Responsible for responding and reporting incidents to FDA, EU, and all other markets LightMed USA products are registered.

Maintain, Coordinate and Enhance the Document Control Program

  • Maintain, organize and file company controlled quality documentation, including quality records and reports.
  • Maintain and develop the Controlled Document Master List, ECN log, and other tracking database tools as needed.
  • Maintain Document Control Metrics for company Management Review reporting
  • Distribute released controlled documentation and retrieve obsolete documents as required.
  • Achieve technical and stylistic consistency in written quality documents to prevent contradicting information.
  • Ensure that all procedures are reviewed and updated at least bi-annually per internal requirements.
  • Coordinate transfer of files to record retention and maintain files archived in that location.

Expected Competencies:

  • Excellent written/verbal communication skills with attention to accuracy.
  • Attention to detail and excellent organizational skills.
  • Ability to work and multitask in fast-paced environment with firm deadlines.
  • Must be able to work independently, take initiative, assume responsibility, and make decisions in an effective and efficient manner.
  • Ability to maintain strict confidentiality and discretion.
  • Strong organizational and self-management skills.
  • Ability to take direction and prioritize as needed.
  • Ability to work easily with R&D Team with focus on transferring new technologies and features to compile documents to support the quality system
  • Ability to work easily with Engineers to manage quality documents for manufacturing
  • Ability to work with Sales & Marketing team to manage documents and modifications required for business development

Desired Qualifications:

  • At least 1 year of work experience required
  • Medical Device & Manufacturing regulatory experience preferred but not required
  • BSEE
  • Understanding sales, marketing, engineering and R&D processes in FDA regulated medical device environment.

At LightMed USA, we offer a great work environment with growth opportunities and comprehensive training program to all our employees, supported by a competitive benefits package that includes:

  • A competitive salary package.
  • Paid vacation and Sick Leave
  • An incentive program based on key performance indicators that drive our business.
  • Medical Insurance and Eye Care Insurance.

United States

San Clemente, California

1130 Calle Cordillera
San Clemente, CA 92673
USA

phone 949-218-9555

fax 949 218 9556

Japan

Tokyo, Japan

3F Orchis-Takebi, 2-Chome 22-1
Hatagaya, Shibuya, Tokyo 151-0072
Japan

phone +81 3 5333 2411

fax +81 3 5333 2412