Associate Manager - Regulatory Affairs & QA

B. Braun; Jakarta Utara; On-site; IDR 100.000.000 - 200.000.000; Full time

Job summary

A leader in the medical devices industry is seeking an Associate Manager for Regulatory Affairs & QA. This role involves implementing regulatory frameworks, managing product approvals, and ensuring compliance with regulations. Candidates must have a degree in Pharmacy and a minimum of 10 years of experience in medical device regulatory affairs. Benefits include company devices, medical insurance, and team-building activities. Join us to help shape the future of healthcare in Jakarta Utara!

Benefits

Company devices provided

Medical insurance

Regular team building and employee social gatherings

Qualifications

• Minimum a degree in Pharmacy.
• Min 10 years of working experience in Medical Devices regulatory affairs.

Responsibilities

• Implement the regulatory framework for product registration.
• Manage regulatory submissions and pre‑market registration.
• Coordinate and prepare regulatory submissions and strategies.
• Support product development teams.
• Monitor adverse effects of medical device products.

Skills

Regulatory compliance

Advisory skills

Project management

Communication

Education

Degree in Pharmacy

Job description

Associate Manager - Regulatory Affairs & QA

Are you passionate about regulatory compliance? If so, this opportunity could be for you! Join us at B. Braun Indonesia, a leader in the medical devices industry, where your skills and experience will be recognized and celebrated. Take the next step in your career with us and help shape the future of healthcare!

As a Associate Manager Regulatory Affair & QA at B. Braun you will play a vital role in organizing, monitoring, protecting and supporting the Medical Devices business by implementing the regulatory framework in the context of product registration (new registration, renewal, variation), promotion compliance, vigilance, quality assurance, CDAKB, CPAKB and other related B. Braun medical device products.

Key Responsibilities

• Protect and support B. Braun’s business, innovation, and assets by implementing the regulatory framework and act as regulatory advisor in building and defending B. Braun.
• Manage the appropriate regulatory submission and pre‑market registration, while interacting with health authorities to obtain and maintain product approvals.
• Coordinate and prepare regulatory submissions and strategies.
• Support product development teams and other product development initiatives.
• Provide regulatory guidance to department or development project teams regarding design, development, and evaluation.
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• Monitor and report the effectiveness and any adverse effects or side effects of medical device products on the market in the general population and in hospitals and research trials.

What you will bring to the team

• Minimum a degree in Pharmacy.
• Min 10 years of working experience in Medical Devices regulatory affairs, CDAKB and CPAKB.

What we can offer you

• Company devices provided.
• Medical insurance.
• Regular team building and employee social gatherings.

We appreciate different perspectives, thoughts, experiences and backgrounds. By strengthening an appreciative, inclusive, respectful and equal working environment, we create a culture in which all our employees feel free to be who they are.