Quality Assurance Regulatory Affairs Manager

About Us Vivo Surgical is Southeast Asia’s pioneering surgical technology disruptor, engaged in developing innovative medical device solutions for better surgeries. An ISO 13485 certified company with international accreditations such as the US FDA and EU CE Mark, our products target the medical needs of the world through innovative Our technologies...

**Job Summary** The Quality Assurance & Regulatory Affairs, Executive will report to the Regulatory Affairs & Quality Assurance, Manager and he/she will assume primary responsibility in providing quality assurance and control expertise to the Menarini team and Partners; and support the Regulatory Affairs & Quality Assurance, Manager in the regulatory...

**Responsibilities**: - Obtain timely renewal of product licenses and maintain registration database - Ensure appropriate licensing, regulatory, marketing and legal compliance of products in each country with the support of local regulatory/distribution partner - Liaise with regulatory bodies and distribution partners in the region to maintain product...

Quality Assurance and Regulatory Affairs ProfessionalThis role involves overseeing quality assurance activities, ensuring compliance with regulatory requirements, and providing guidance on quality management systems.Key Responsibilities:Develop and implement quality assurance strategies to ensure products meet legal and customer requirementsDrive continuous...

Director of Regulatory Affairs and QualityDirector of Regulatory Affairs and QualityDirect message the job poster from Barrington JamesHead of Regulatory Affairs & Quality, Asia.I am engaged by a global medical devices company to appoint a Head of Regulatory Affairs and Quality for Asia.This senior leadership position will guide regulatory direction and...

Roles & ResponsibilitiesAt Majeton, we are driven by our commitment to deliver "The Right Product for Health". Our team of researchers and clinical experts utilize clinic feedback from practitioners, scientifically researched literature and top quality manufacturing as the foundation for all products.We are seeking a meticulous and experienced Quality &...

**Specific duties include but are not limited to**: - Lead and manage a team of regulatory and quality professionals, fostering a culture of excellence, collaboration, and continuous improvement including: creating regulatory strategies, preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to...

**Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-179384 **Contact** Roselle Cuntapay **Posted** about 3 hours ago - Currently recruiting for a Regulatory Affairs Specialist for a small Medical Device business. Their product is currently in a couple of markets (and doing well) but they are...

Develop and implement regulatory strategies to secure product approvals more quickly than competitors. - Lead complex decision-making processes among stakeholders and senior leadership in a dynamic regulatory environment. - Provide expert advice on regulatory strategy, Health Authority engagement, and submission activities for the IVD product lines. -...

Develop/ enhance procedures to ensure compliance with industry standards and regulations - Assist, manage and maintain documentation and records necessary for quality management system (QMS) and regulations compliance - Support e-QMS implementation - Proofread documents - Assist in ad-hoc duties and tasks when assigned - Open to all faculties, mínimally...