Senior Regulatory Affairs Specialist, APAC

Zoll Medical Corporation is seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team in the Asia Pacific region. In this role, you will be responsible for ensuring compliance with regulatory requirements for our medical devices, including those in Indonesia. You will work closely with our global regulatory team to develop and implement strategies that ensure our products meet the highest standards of safety and efficacy.

This is an exciting opportunity to be part of a dynamic and innovative company that is at the forefront of the medical device industry. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.

If you are a passionate and driven professional with a strong background in regulatory affairs, we encourage you to apply for this position.

📋 Tanggung Jawab Pekerjaan

Tanggung Jawab:

• Ensure compliance with regulatory requirements for our medical devices in the Asia Pacific region, with a focus on Indonesia.
• Develop and implement strategies to ensure our products meet the highest standards of safety and efficacy.
• Work closely with our global regulatory team to develop and implement strategies that ensure our products meet the highest standards of safety and efficacy.
• Monitor regulatory changes and trends, and develop strategies to ensure our products remain compliant.
• Provide guidance and support to our local regulatory team in Indonesia.
• Develop and maintain regulatory documentation, including submissions to regulatory authorities.
• Conduct audits and inspections to ensure compliance with regulatory requirements.
• Collaborate with our marketing and sales teams to ensure our products are marketed and sold in compliance with regulatory requirements.

🎓 Kualifikasi & Syarat

Kualifikasi:

• Bachelor's degree in a relevant field, such as pharmaceutical sciences, regulatory affairs, or a related discipline.
• Minimum of 5 years of experience in regulatory affairs, with a focus on medical devices.
• Strong understanding of regulatory requirements in the Asia Pacific region, with a focus on Indonesia.
• Excellent written and verbal communication skills, with the ability to communicate complex regulatory information to a variety of stakeholders.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a team.
• Familiarity with regulatory software and tools, such as Medidata or Regulatory Affairs Management Systems (RAMS).
• Experience with regulatory submissions to regulatory authorities, such as the Indonesian Food and Drug Administration (BPOM).

🛠️ Keahlian

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