Quality Officer

2 weeks ago


Bayan Lepas, Malaysia Leonix Sdn Bhd Full time

Responsibilities:

Regulatory Compliance:
Ensure compliance with all relevant regulations, laws, and guidelines pertaining to [industry/sector] products/services in various jurisdictions.

Documentation Management:
Develop and maintain regulatory documentation, including product registrations, submissions, dossiers, and technical files.

Regulatory Strategy:
Collaborate with cross-functional teams to develop and execute regulatory strategies, including product approvals, licensing, and post-market surveillance.

Risk Assessment:
Conduct risk assessments to identify potential regulatory issues and provide recommendations to mitigate risks.

Regulatory Submissions:
Prepare, review, and submit regulatory filings to regulatory authorities, such as FDA, MDR, and other relevant bodies.

Quality Assurance:
Ensure compliance with quality management systems and standards, such as ISO 13485 and Good Manufacturing Practices (GMP).

Regulatory Intelligence:

Stay up-to-date with regulatory developments, changes, and trends in the medical devices landscape and communicate their impact to relevant stakeholders.


Interdepartmental Collaboration:

Collaborate with cross-functional teams, including R&D, quality assurance, clinical affairs, and marketing, to ensure regulatory requirements are met throughout the product lifecycle.


Audits and Inspections:
Assist in internal and external audits and inspections to ensure regulatory compliance and address any findings or deficiencies.

Training and Education:
Provide training and guidance to internal stakeholders on regulatory requirements, policies, and procedures.

Qualifications:

  • Bachelor's or Master's degree in a related field (e.g., Regulatory Affairs, Life Sciences, Biomedical Engineering).
  • Strong knowledge of relevant regulations and guidelines in [industry/sector] (e.g., FDA, EMA, ICH, ISO).
  • Experience in regulatory affairs within the medical device industry, preferably.
  • Familiarity with quality management systems (e.g., ISO 13485, ISO 9001) and regulatory compliance standards.
  • Excellent analytical and problemsolving skills with a keen attention to detail.
  • Effective communication and interpersonal skills to collaborate with internal teams and external stakeholders.
  • Ability to prioritize tasks and work independently in a fastpaced environment.
  • Proficiency in using regulatory databases, document management systems, and Microsoft Office Suite.

Pay:
RM2, RM3,000.00 per month

Benefits:

  • Health insurance
  • Maternity leave
  • Opportunities for promotion
  • Parental leave
  • Professional development

Supplemental pay types:

  • Attendance bonus
  • Overtime pay

Ability to commute/relocate:

  • Batu Maung: Reliably commute or planning to relocate before starting work (preferred)

Application Question(s):

  • Keen on taking the challenge together with the team?

Education:

  • Bachelor's (preferred)

Experience:

Regulatory Affairs: 1 year (preferred)

Language:

  • English, Malay (preferred)

Willingness to travel:

  • 50% (preferred)

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