Job Description

Our client is seeking a commercially astute Regulatory Affairs Director to lead their APAC regulatory team and support the growth and sustainability of the IVD business in APAC.

Client Details

Our client is a strong global brand name in the healthcare sector. They have an experienced and visionary leadership team who has led the continual growth and expansion of their APAC footprint in the last few years.

Description

• Provide leadership to develop and implement regulatory strategies throughout the product lifecycle that are consistent with business unit goals and objectives
• Drive regulatory planning and execution to ensure alignment with business and functional goals and priorities with speed, adaptability, with high quality
• Strategize and develop regulatory plans and documents for new products, product updates, manufacturing process changes, marketing materials, and clinical trials
• Lead and develop the regulatory team and develop strong influence with external regulatory relationships with regulatory bodies and trade associations.
• Be a leader- positive, forward looking, accountable, action-oriented, delivering results
• Communicate regulatory strategies and project status to internal stakeholders

Profile

• Bachelor\'s degree in engineering or Science, Biomedical or other science related field.
• At least 10 years of Regulatory Affairs or equivalent leadership experience
• Technical, scientific and clinical experience with Medical Devices preferred
• Proven ability to lead, build, and to develop organizations in a fast-paced, energized, dynamic work environment
• Solid experience and proven track record in successful regulatory submissions
• Effectively communicates ideas and information clearly to leadership, teams more broadly to internal and external stakeholders
• Possess strong experience in medical device regulatory frameworks and policies in APAC

Job Offer

Our client is offering an exciting opportunity for the right individual to scale up into a senior leadership position. You will be working closely with a high performing team with a collaborative culture. This position offers autonomy and high level of independence, if you are the right candidate for the role, please apply at the link.

To apply online please click the Apply button below. For a confidential discussion about this role please contact Eugenia NG (Lic No: R1108105) on +65 6541 9961.

Michael Page