Regulatory Affairs Executive

1 week ago

Singapore ABIORES PTE. LTD. Full time
Roles & Responsibilities

Job Responsibilities:

  1. Support product registration activities, including the preparation of registration dossiers, performance evaluation study design, and coordination with CROs (Clinical Research Organizations).
  2. Act as the subject matter expert on medical device regulatory requirements, with a particular focus on FDA regulations. Stay current with relevant laws and ensure internal practices remain compliant.
  3. Interface with global regulatory authorities such as the FDA, Health Sciences Authority (HSA), and Medical Device Authority (MDA). Track submission progress and manage responses to queries or objections during the review process.
  4. Participate in clinical verification, product testing, data collection, and ongoing tracking activities to support both regulatory submissions and product performance validation.
  5. Prepare and submit scientific and technical documentation for special projects or novel product classifications.
  6. Foster professional relationships with regulatory bodies, third-party experts, and key opinion leaders to strengthen regulatory pathways and advocacy.
  7. Collaborate cross-functionally with internal teams (e.g., R&D, Clinical, Quality Assurance) to align regulatory strategy with overall business goals.
  8. Undertake any additional regulatory tasks or projects as assigned by the management team.

Job Requirements:

  1. A Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related discipline.
  2. Minimum 2 years of hands-on experience working with the FDA on medical device registration, submissions (e.g., 510(k), IDE), or related regulatory pathways.
  3. Demonstrated skills in project management, planning, execution, and timely communication. Strong presentation and technical writing abilities are essential.
  4. Enthusiastic, proactive, and professional work ethic with a high level of accountability. Strong interpersonal skills and the ability to collaborate across teams.
  5. Detail-oriented with a high degree of responsibility. Able to handle regulatory pressure and manage tight timelines effectively.
  6. Willing and able to travel to the United States for one month every six months as part of regulatory project and stakeholder engagement needs.
Tell employers what skills you have

FDA
Clinical Research
Technical Writing
Quality Assurance
Interpersonal Skills
Regulatory Affairs
Regulatory Strategy
Biomedical Engineering
Stakeholder Engagement
Advocacy
Pressure
Regulatory Requirements
Health Sciences
Life Sciences
Regulatory Submissions

  • Head of Regulatory Affairs

    7 days ago

    Singapore Keller Executive Search Full time

    The Head of Regulatory Affairs will be responsible for ensuring that our company complies with all relevant regulations and laws. This role requires a deep understanding of the pharmaceutical industry's regulatory environment and involves developing regulatory strategies, overseeing regulatory submissions, and liaising with regulatory bodies. Job...

  • Regulatory Affairs Executive

    5 days ago

    Singapore Superform Consulting Pte Ltd Full time

    Job Title : Regulatory Affairs Executive Location: Tuas **Salary**: $4500-$6000 Working Days: Mon -Fri Working Hours: 7.45AM-4.45 PM Job Duties - Prepare and maintain the registry of all products registered locally and internationally. - Prepare and maintain the markets regulatory requirements for implementation in the company. - Follow-up on any...

  • Regulatory Affairs Executive

    7 days ago

    Singapore Hays Full time

    **Your new company** Join one of the leading pharmaceutical company today! Excellent opportunities for learning in Regulatory Affairs work. **Your new role** - Communicate with regulatory authorities as well as overseas counterparts with regards to regulatory affairs matters such as product registrations, changes in existing products and renewals - Ensures...

  • Regulatory Affairs Executive

    3 days ago

    Central Singapore Emprego SG Full time

    **Location** - Singapore, Central Singapore**Job Type** - Permanent**Salary** - $4,000 - $7,000 Per Month**Date Posted** - 2 hours agoAdditional Details **Job ID** - 113486**Job Views** - 1Roles & Responsibilities **Our client is a Consumer Health MNC, one of the leading players in the sector. Due to business needs, they are now recruiting Regulatory...

  • Regulatory Affairs Executive

    2 weeks ago

    Singapore Hyphens Pharma International Limited Full time

    COMPANY DESCRIPTION **Listed on the Catalist board of the Singapore Exchange (SGX), Hyphens Group has a direct presence in Singapore (HQ), Vietnam, Malaysia, Indonesia and the Philippines, and is supplemented by a marketing and distribution network covering additional jurisdictions like Hong Kong, Myanmar, Brunei, Cambodia, Oman, Bangladesh, South Korea and...

  • Regulatory Affairs Executive

    9 hours ago

    Singapore FUJIFILM HEALTHCARE ASIA PACIFIC PTE. LTD. Full time

    Full awareness of local Health Products and Medical Device Act and their regulations relevant to the business through regularly checking HSA websites and attending HSA briefings; - Communicate changes and new requirements to management; - Meet, discuss and negotiate with HSA regulators on matters pertaining to product registrations; - Have working knowledge...

  • Regulatory Affairs Professional

    2 weeks ago

    Singapore beBeeRegulatory Full time

    Regulatory Affairs Specialist RoleWe are seeking a skilled and detail-oriented Regulatory Affairs Specialist to support our regulatory activities.This role will involve assisting with the submission of applications and variations for clinical trials and marketing authorisation across all pipelines.Main Responsibilities:Submission Support: Assist with the...

  • Regulatory Affairs Executive

    9 hours ago

    Singapore Employment Vietnam Full time

    **Summary**: Our client is a UK-based multinational company specializing in the creation of original fragrances and flavors. They are seeking a talented individual to join their team as a Regulatory Affairs Executive Primary **Responsibilities**: - Provide technical documentation to our customers in a timely manner. - Advise customers on products...

  • Regulatory Affairs Executive

    1 day ago

    Singapore NESTLE SINGAPORE PTE LTD Full time

    **A day in the life of...** - Regulatory Compliance (Recipe check, regulatory input on label, label approval, communication materials) - Compliance Check & Review - Label-D System Implementation and Training - Inter Market Supply Product Brief (IMSPB) (SG as Importing Market) - Maintain Documentation - Support Regulatory Projects **What will make you...

  • Regulatory Affairs Executive, Apac

    2 weeks ago

    Singapore Symrise Full time

    **About Symrise AG** Symrise is a global supplier of fragrances, flavors, food, nutrition, and cosmetic ingredients. Its clients include manufacturers of perfumes, cosmetics, food and beverages, pharmaceuticals and producers of nutritional supplements and pet food. Its sales of € 3.8 billion in the 2021 fiscal year make Symrise a leading global provider....