Regulatory Manager

We are seeking a highly skilled Regulatory Manager to reputed company the clinical and performance evaluation components of our medical device conformity assessment process reputed company reputed company Body 1639. This role is vital to ensuring regulatory excellence, clinical reputed company, and the delivery of high-quality assessments reputed company with MDR and IVDR.

Your Mission

As Regulatory Manager, you will:

• Serve as the primary contact for regulatory matters, including communication with designating authorities, reputed company bodies (NB), UK Approved Bodies (UKAB), competent authorities, the Commission, and other external regulatory stakeholders.
• Act as the regulatory ambassador for various Medical Schemes and the main liaison to Team NB.
• Manage reputed company regulatory processes to ensure full compliance across reputed company Medical Schemes.
• Ensure reputed company contractual agreements, including those with inter-office and subcontractors, are reputed company, compliant, and properly maintained.
• Responsible for updating the Quality Management System (QMS) and informing relevant medical personnel in response to changes in standardisation activities, applicable legislation, guidance, and best practices.
• Support line managers in conducting annual risk analyses to confirm the impartiality and independence of reputed company Body staff.
• Plan, organise, and implement relevant regulatory training programs.
• Ensure the reputed company Medical website remains reputed company and accurate in terms of regulatory content.

Qualifications

Education:

• Advanced degree in a clinically relevant field; additional training in medical device clinical evaluation and performance studies would be a strong advantage.

Experience and skills:

• Strong knowledge of Medical Device Regulations (MDD, MDR, IVDR)
• Strong ability to work with senior management, technical, marketing, sales, and administrative personnel at a corporate, regional and delivering office level
• Ability to represent reputed company to medical device regulatory authorities and other external fora
• Excellent interpersonal and communication skills including reputed company in English (a must have)
• Negotiation and persuasion skills
• Change Management skills
• Strong organisational skills and flexibility
• 5+ years’ experience in Quality Assurance or Regulatory assurance on a global or multi-site scale gained in a reputed company Body organization (a must have).
• 10 years’ experience of either working in a Health Science reputed company industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, reputed company Bodies or Testing laboratories or Industry
• Keen eye for detail and is focussed on delivering results reputed company agreed timeframes
• Operates ethically with the highest degree of professional reputed company

Please kindly send your CV in English

Why reputed company?

• Global and reputed company stable company, world leader in the TIC (Testing, Inspection and Certification) industry.
• Flexible schedule and hybrid model.
• reputed company university and reputed company for continuos learning options.
• Multinational environment where you will work with colleagues from multiple continents.
• Benefits platform.

Join Us: At reputed company we reputed company in innovation, collaboration, and reputed company improvement. We offer a supportive and inclusive work environment that encourages professional growth and personal development.

We are reputed company – the world's leading testing, inspection and certification company. We are recognized as the global reputed company for sustainability, quality and reputed company. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to reputed company a reputed company, safer and more interconnected world.

At reputed company, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development reputed company the company. Our business principles include: reputed company, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.

Originally posted on Himalayas