Monroe Recruitment Consulting Group Co., Ltd.

Regulatory Affairs Manager (Medical Devices), Bangkok, Thailand

Monroe Recruitment Consulting Group Co., Ltd.
THB 90,000 - THB 120,000 /month (negotiable)
Posted on 21 Jan 2021

Regulatory Affairs Manager (Medical Devices), Bangkok, Thailand

Monroe Recruitment Consulting Group Co., Ltd.

Job Highlights

  • International Environment
  • Working closely with Managing Director.
  • Opportunity to lead the team

Job Description

Salary: Attractive

Additional Benefits: Attractive

Company Profile

Executive recruitment company Monroe Consulting Group Thailand is recruiting on behalf of one of the largest integrated solutions providers of medical equipment, supplies and services in Asia.

Job Summary

The position will mainly manage the regulatory authority for company’s devices

Job responsibilities

  • Ensuring compliance to the legislative requirements.
  • Prioritization and timeliness of product registrations with the relevant Government Authority.
  • Follow through diligently with the product owners/principal and government authority in cases of product rejection or delay to resolve such delays. Maintain the validity of the Registered Product list, import/wholesale license and/or any relevant licenses.
  • Manage activities such as regulatory agencies inspections, or product recalls accordingly to the SOP.
  • Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
  • Provide regulatory guidance to departments or developmental project teams regarding design, labelling, development and evaluation of products
  • Ensure the compliance of the product labelling and storage condition (temperature & humidity) of the registered product.
  • Create and deliver strategic regulatory guidance for assigned projects/products. Strategies should be in alignment with global/regional positions, commercial goals, and key stakeholders/partner lines.
  • Lead and/or participate in global, regional and/or in-country Regulatory Teams for assigned projects/products.
  • Establish procedures or systems for publishing documents submission either on electronic or hard copy
Job requirements

  • A university degree in science, with pharmacy / pharmacology preferred
  • Experienced in medical devices registration
  • Over 8 years work experience in related industry
  • Good leadership skills with ability to work independently
  • Good command in English
INTERESTED? All applications will be treated in the strictest confidence. If you are a suitable match for this position please simply click the APPLY button below and please ensure that your CV is a WORD document and not a PDF

Additional Information

Career Level
Senior
Qualification
Degree
Years of Experience
5 years
Job Type
Full Time

Company Overview

THE COMPANY

Monroe Consulting Group is a leading provider of senior human resource capital, specialising in servicing the worlds emerging economies within the Professional Services, Technology, Industrial, Health and Consumer Goods sectors. Established in 1998, we have offices in Thailand, Indonesia, Malaysia, The Philippines, China, and Vietnam.

OUR BRAND

Our brand is built around quality, professionalism, and very high ethical standards. Our Recruitment Consultants are all highly trained and work unique specialist markets which truly allows them to understand the needs of both our clients and candidates. In a world where quality attracts quality and results can be all that matter, Monroe is your committed advocate and the best external ambassador you could ever wish for.

AWARD WINNING RECRUITMENT

Monroe Consulting Group has won a total of 25 international recruitment awards to include being voted Best Recruitment Company APAC 5 times, Best Overseas Operation twice and Best In-House Trainer at the Global Recruiter Awards. We also been voted Best Consultancy at The Thailand Expat Awards and Best SME at the Thailand Entrepreneur Now Awards.

WHAT OUR CLIENTS THINK

"Monroe have been superb, their customer service is great. The team there respond very quickly and go above and beyond to help throughout the recruitment process. I am always impressed with the service orientation I find when I interact with the Monroe team.” People & HR Manager - FMCG

“Monroe Consulting played a big role in expanding our organization. They understand our business, our requirements, and provide good information about the market. We are very happy with the quality of the candidates they present, and exceeded our expectations in coordinating with candidates, starting from setting up the interviews, up to the closing stage. We appreciate their honesty and professionalism. We would rate the service that they provide as excellent!” HR Director - Manufacturing

Additional Company Information

Benefits & Others
Five-day work week, Medical insurance, Performance bonus, Transportation allowance, Travel allowance