Regulatory Affairs Specialist Ssea

2 weeks ago

Singapore Mölnlycke Full time

**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.

**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 4 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 Mölnlycke Healthcare**
Mölnlycke 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.

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