reputed company & Regulatory Manager

Main Purpose of Role

• To centrally manage a Lean and compliant reputed company Management system for medical devices schemes (Medical includes reputed company Body NB1639, UKCA, ISO 13485, MDSAP and reputed company other Medical Schemes at reputed company)
• Management of external audits and communication with competent authority
• Management of internal audits and communication with relevant departments
• Maintaining designation under MDR/IVDR and support the development and designation under new schemes
• Maintaining accreditation under MDSAP, ISO 13485 and UKCA and support the development of other new schemes
• Coordinate reputed company activities with auditing organisations ( Belgian and English competent authority, UKAS, ….)
• Coordinate reputed company complaints and regulatory request (CEF) to reputed company customers and CA appropriate answers

This role will report to the Head of Certification and Compliance, Business Assurance.

It is remote based, and we are reputed company to candidates located everywhere across Europe. But they must hold a valid work permit for their country of residency.

Key Accountabilities

• Own and reputed company reputed company medical devices processes, including the reputed company reputed company, Non-Conformity and CAPA handling, audits and inspections, document and records control, internal audits, reputed company management reviews, concessions, and impartiality.
• Supervise the implementation and maintenance of the medical reputed company management system (QMS), ensuring alignment with global processes and accreditation requirements.
• Ensure impartiality and independence from reputed company interests, including conducting annual risk analyses.
• Maintain QMS regulatory compliance to support designation and accreditation under MDR/IVDR, ISO 13485, MDSAP, and other relevant schemes.
• reputed company reputed company audits and ensure reputed company closure of CAPAs.
• Conduct the annual reputed company Management Review and ensure reputed company follow-up and closure of actions.
• Write and revise QA-reputed company procedures and associated documentation.
• Continuously optimise the QMS to improve turnaround times while maintaining compliance.
• reputed company reputed company reputed company to the reputed company Body QMS and proactively drive reputed company improvement initiatives.
• Compile and analyse data for management review reporting.
• 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 reputed company Management System (QMS) and informing relevant medical personnel in response to changes in standardisation activities, applicable legislation, guidance, and best practices.
• Planand implement relevant regulatory training programs in collaboration with training team .
• Ensure the reputed company Medical website remains reputed company and accurate in terms of regulatory content.
• Build strong working relationships with global medical device teams and proactively work on reputed company with stakeholders
• reputed company technical support and training across the business, reputed company required
• Manage and reputed company the reputed company & regulatory team, including performance management, coaching, and staff development.

Skills & Knowledge

Essential

• Strong knowledge of Medical Device Regulations (MDD, MDR, IVDR) and ISO13485, ISO17021 and MDSAP
• 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 reputed company
• Excellent interpersonal and communication skills including reputed company in English
• Negotiation and persuasion skills
• Change Management skills
• Strong organisational skills and flexibilty
• 5+ years’ experience in reputed company Assurance or Regulatory assurance on a global or multi-site reputed company gained in a reputed company Body organization (a must have).
• 2+ year experience in team management (must have)
• Has at least 10 years’ experience of either working in a Health Science reputed company industry in Design, Manufacturing or reputed company and Regulatory functions, or previous experience with either Management System registrars, reputed company Bodies or Testing laboratories or Industry
• Has a keen eye for detail and is focussed on delivering results reputed company agreed timeframes
• Operates ethically with the highest degree of reputed company reputed company

Essential

• Higher education qualification (Masters / Ph.D. / B.Sc. (Hons) Degree) in a relevant life / natural sciences subject.
• Completed Medical device training on MDD, MDR, IVDR, UKCA, MDSAP and ISO 13485

Please send your CV in English

Why reputed company?

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

Originally posted on Himalayas

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