Regulatory Affairs (RA) Specialist

Who We Want:

Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.

Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

 

What You Will Do:

The role is responsible for the registration maintenance of existing products and the management of regulatory submissions for new product registration for HeMo’s Medical Device Division in the APAC, European and US region, whilst ensuring compliance with the relevant legislation, industry standards and HEMO policies.

 

Responsibilities:

  • Manage independently all government product registrations/ change notifications/ re-registrations/ license renewals/ input requests-questions and other related actions to ensure timely initiation and closures per internal and regulatory deadlines to be in line with product launch/business plans. Prepare, submit, and follow up consultations on applicable regulations on company products and processes. Support customers/ dealers/ partners in our markets likewise where HeMo entity is not the product holder and ensure their timely registration/ license renewal success.
  • Maintain regulatory trackers and manage the filing and record keeping of regulatory documentation.
  • Thorough understanding of the legislation and medical device standards in our target markets to ensure best business outcomes. Provide regulatory advice and expertise in projects including but not limited to acquisition integration, new product introduction, product lifecycle management.
  • Identify and assess potential changes to relevant legislation and medical device standards within our target market regions and effectively communicate the impact to key stakeholders.
  • Supporting Post Market Activity and ensuring timely and correct reporting/ follow up to authority.
  • Keeping abreast of regulatory procedures and changes in the regions, advise and strategize with upper management, keeping them informed of the regulatory development and advising on the methods to execute contingency methods as needed.
  • Responsible for coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections and attending to external auditor.
  • Develop and review internal policies that relating to the manufacture, testing, sales & marketing and reliability of products to ensure compliance of the regulatory requirements.
  • Any other ad hoc projects as assigned.

 

Job Requirements:

  • Minimum bachelor’s degree in pharmacy, biomedical sciences or related
  • Minimum 5 years’ experience in regulatory affairs function in the relevant industry.
  • Good communication, negotiation and co-ordination skills are required to liaise with internal and external colleagues and service providers.
  • Excellent planning and time management skills.
  • Meticulous and attention for details.
  • Be a team player, with excellent administration skills
  • Regulation knowledge on medical devices.
  • Proactively seeks to develop and become well-versed within the regulatory landscape.

 

Interested candidates should send an updated CV to the below, with email heading “APPLICATION FOR REGULATORY AFFAIRS SPECIALIST”:  Recruit@hemocorp.com

We regret that only shortlisted candidates will be contacted.

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