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Senior Regulatory Affairs Specialist

3 months ago

Ho Chi Minh City, Ho Chi Minh, Vietnam Thermo Fisher Scientific Full time
The Senior RA Specialist will provide expertise to help optimize and accelerate product registrations in Vietnam).

The position is part of the APAC Regional Regulatory Affairs team, supporting the Specialty Diagnostics Group within Thermo Fisher Scientific.

The position contributes to the growth in the region, by driving the right strategic decisions for effective regulatory pathway to optimize and accelerate the time to market in Southeast Asia.


Key Responsibilities:

  • Perform and complete regulatory submissions (Renewals and Expansion of the product portfolio) to the Vietnam authorities, timely.
  • Define, implement and complete effective regulatory processes of Thermo Fisher Scientific Specialty Diagnostic Group in compliance with respective Authority requirements in Vietnam.
  • Partner and work proactively with the Vietnam stakeholders, examples; Country Commercial Leaders/teams and Channel Partners/ Distributors to ensure the optimal regulatory strategy in compliance with the legislation in the respective country.
  • Support and continuously monitor Vietnam distributor's performance on timely renewals, regulatory submission and compliance.
  • Review of dossier files before submission and collaborating with Global & Regional Regulatory team to resolve technical and documentation gaps and recommending responses to the questions from health authorities.
  • Coordinate and provide assessment to market responses or needs and provide change management assessment. Ensure the regulatory change and compliance will not impact the product in the market.
  • Serve as Subject Matter Expert of Vietnam regulatory landscape and intelligence communicating regulatory and compliance changes to the Regulatory teams (global and regional) on the impact and action required.
  • Ensure that Specialty Diagnostic Group in Vietnam is in compliance with the latest Medical Device and IVD regulations building advocacy and rapport with regulatory authorities.
  • Be the voice of Thermo Fisher Southeast Asia and actively involved in Vietnam regulatory association.
  • Ensure Global Post Market Surveillance activities, for example, field safety notification, recall and other postmarket surveillance are in compliance with Vietnam reporting requirements.
  • Review labeling and promotional materials for regulatory compliance within Vietnam.

Education:

  • Bachelor's degree in biomedical engineering or equivalent.

Experience:

-
5 years of relevant work experience in Regulatory Affairs in either in-vitro diagnostic and/ or medical device industries.,

  • Project Management experience demonstrating ability to optimally lead regulatory projects.

Knowledge/ Skills and Qualification:

  • Knowledge of in vitro diagnostic and/ or medical device registration and submission process in Vietnam. Knowledge for ASEAN (Southeast Asia) countries is an additional advantage.
  • Working experience in direct submission to the authority and ability to respond optimally to authority queries.
  • Able to cultivate positive working relationship with internal partners in a matrix environment and with external partners, for example, distributor, authorities.
  • Ability to priorities time effectively and meet agreed timelines.
  • Demonstrate good ability to identify internal & external customer's needs and challenges and to recommend realistic solutions to meet the needs of the business.
  • Experience in handling distributors and contacts with local industry regulatory associations
  • A good team player, who is able to work with the team members across the different countries, and who can also work independently. Positive demeanor and be proactive pragmatic and willing to learn.
  • A good command of verbal and written communication skills in Vietnamese and English is essential. Spoken communication must be clear and confident and must show evidence of good listening skills.


Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.