Senior Regulatory Affairs Specialist

Baxter International Inc.; Petaling Jaya; On-site; MYR 45,000 - 85,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to provide regional support for medical device product development. This role is crucial in ensuring compliance with local regulations and managing regulatory submissions. You will work closely with cross-functional teams to navigate regulatory challenges and drive operational excellence. If you have a passion for improving healthcare outcomes and possess strong project management and communication skills, this opportunity will allow you to make a significant impact in a collaborative environment dedicated to saving and sustaining lives.

Qualifications

• 6+ years in medical devices industry with regulatory expertise.
• Strong knowledge of regulatory laws and compliance risks.

Responsibilities

• Develop and execute regulatory project plans with direction.
• Compile and submit regulatory documents ensuring compliance.

Skills

Regulatory Project Management

Risk Assessment

Communication Skills

Negotiation Skills

Technical System Skills

Education

Bachelor's Degree in Pharmacy

Equivalent Science Degree

Tools

Database Management

Word Processing

Spreadsheets

Job description

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

• This role provides regional regulatory support for new product development activities and post market support. The product portfolio consists of medical devices. Responsibilities include preparing and implementing regulatory plans, supporting regulation changes and completion of regulatory deliverables. This includes managing local regulatory registrations with the global teams, impact assessments, new registrations, post-approval changes, and renewal, liaising with internal and external stakeholders in fulfillment of responsibilities.

Essential Duties & Responsibilities

• With direction, develop and execute regulatory project plans.
• Identify and elevate key areas of regulatory risk.
• Maintain awareness of regulatory requirements; identify relevant requirements.
• Maintain regulatory files in a format consistent with requirements.
• Participate as an active team member and provide regulatory advice to project teams as required.
• Respond to questions from regulatory authorities within strict timelines
• Compile, prepare and submit new registration, variations, change notifications, renewals and ensure approvals in a timely manner according to regulatory requirements.
• Prepare, review, and approve labeling and review AdProm materials for compliance with local regulations.
• Represent or lead Regulatory Affairs in small project teams.
• Submit PMS, FA, complaints to HA in Singapore and Malaysia.
• Learn, drive and manage various databases and reports ensuring information is accurate and up to date.
• Participate and maintain working relationships and provide regulatory intelligence to relevant functional and business unit's team members.
• Support the Function in driving RA operational excellence through strategizing and implementing local and/or regional continuous process improvement and/or digitization of procedures.
• Perform other duties as assigned.

Education & Experience

• Bachelor's Degree in Pharmacy, Science or equivalent.
• Minimum 6 years of relevant experience in medical devices industry.
• Well-versed with new registration, license extensions, variations and renewals. Experience with Class II devices onwards is mandatory.
• Knowledge of applicable regulatory laws and acts and well-versed with changing scope and evolving regulations.
• Good understanding of GDPMD.
• Project management skills.
• Ability to multitask and prioritize.
• Good interpersonal and communication skills.
• Negotiation skills.
• Technical system skills (e.g. word processing, spreadsheets, databases, online research).
• Ability to identify compliance risks and escalate when necessary.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

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