Job Description

Are you ready to challenge yourself in a new environment and have a real impact?

At Molnlycke, you\'ll be helping to equip medical professionals with solutions to improve outcomes for patients. And you\'ll develop your career in a growing organization with an inspirational culture-where you\'ll be recognized for the results you\'ve achieved.

Molnlycke APAC in Singapore is hiring for a new role as a Regulatory Affairs Manager/Senior RA Specialist, SSEA to join our global Regulatory Affairs team. Reporting to the RA Manager based in Singapore, the ideal candidate comes with about 7 years of relevant regional experience and comfortable working in a matrix organization.

KEY RESPONSIBILITIES:
Key person to lead and manage registration process to:

• Develop and execute regulatory strategies in the various SSEA countries in close collaboration with commercial and consultants, as applicable in order to obtain authority product license approvals in SSEA.
• Ensure continuity in license approvals in the SSEA region
• Coordinate Regulatory Plan in the SSEA region

Responsible for registration of medical device to ensure registration is process as plan, including:

• Align with commercial on business plan and strategy
• Responsible for managing and supervising regulatory activities in support of both existing and new products, and markets
• Tracking and monitoring timelines for new registrations, renewals and variation approvals.
• Submission and dossier compilation for all SSEA countries; collaboration with consultants and distributors RA
• Communicate and follow up closely with health authority to ensure submission is approved on time.

WHO WE ARE LOOKING FOR:

• Bachelor degree or above
• At least 7 years\' experience in registration
• Familiar with medical device regulation, registration process and requirements in Singapore, India, Malaysia and Thailand will be preferable.
• Proficient in the use of MS Office suite.
• Good communication in English
• Meticulous, preciseness, initiative and strong rationality, strong sense of responsibility and team work

OTHER INFORMATION:

• Office address is in Tiong Bahru office tower
• Hybrid working arrangement

WHAT WE HAVE FOR YOU?

• At Molnlycke, we are committed to being an inclusive organization that gives every one of us a strong sense of belonging.
• You\'ll feel that we have values that put the human being at the center of what we do.
• A multicultural, vibrant work environment where you\'ll have an opportunity to share your ideas and you\'re encouraged to take risks and grow.
• You\'ll be coached in your career, both for professional as well as personal development, particularly through an individualized development plan and available qualitative tools
• Competitive remuneration package, benefits

Our approach to diversity and inclusion
We strive to have a diverse mix of people from different cultures, ages, geographies and genders, to reflect the world in which we operate and to facilitate innovative thinking across the business.

About M\xc3\xb6lnlycke Healthcare
M\xc3\xb6lnlycke Healthcare is a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes.
Our business is organized into four business areas: Wound Care, Operating Room Solutions, Gloves and Antiseptics. Customer centricity, sustainability, and digitalization are at the heart of everything we do.
M\xc3\xb6lnlycke employs around 8,400 people. The company headquarters are in Gothenburg, Sweden and we operate in more than 100 countries worldwide. Since 2007, the company has been part of Investor AB, an engaged owner of high-quality, global companies which was founded by the Wallenberg family in 1916. For more information, please visit www.molnlycke.com and www.molnlycke.com/careers

M\xc3\xb6lnlycke