MDSAP Technical Manager - USA - Circa $140-160k
Location: United States
Support various teams within the Area Operations to assist them to be strategically and commercially aligned to the business whilst preserving Management Systems’ accreditation and other regulatory requirements.
Where allocated, provide specific MDSAP product/scheme specialism by focusing on the training, integration, communication to ensure compliance and governance by effectively interfacing with international contacts and networks within Management Systems as defined within the Global, Area and Local Product Specialist, Guidance document
- Ensure that required MDSAP technical standards are maintained and align to the local and global strategic and commercial needs. Provide feedback and recommendations to Global Medical and Area Management Teams and other Management Systems departments to share best practice and ensure processes are effective.
- Manage the transition plan for accreditation to move from CMDCAS to MDSAP, and provide management of the various activities to ensure implementation is delivered by completing the 3 witness audits.
- Give technical MDSAP support and interpretation of legislation and management system processes, products and procedures to the area technical and operations teams, Field Assessment communities and other management systems departments
- Assist in ensuring that the systems, processes and procedures are effective and efficient, are communicated, objectives are defined and reported on to meet business/ commercial requirements for both internal and external clients for area of responsibility. The procedures must be aligned with the companies Medical Devices Operational Service delivery model.
- To ensure that key governance and system monitoring activities are undertaken within the area of responsibility to support local/global accreditation requirements and LR management systems corporate governance e.g. Internal audits, management review and management of product audit activity for specified product/scheme.
- Provide input into local and area Technical strategies and business plans. Work with Global and Area Technical Manager to translate plans into goals and objectives and implement these within agreed principles, approach and budgets ensure that the systems, processes and procedures are effective and efficient
- Be a focal point for MDSAP specific product / sector scheme and ensure related accreditation knowledge is gathered, effectively at local and global levels within Management Systems through appropriate electronic media in line with Global, Area and Local Product Specialist, Guidance document
- Using local knowledge, assist Global and Area Technical Manager to make recommendation for and represent Management Systems’ business interests on local external accreditation standards and sector scheme committees to build and maintain a strong network and credibility within the industry
- Work with Global and Area Technical Manager to support resolution of unresolved 3rd party complaints, certification disputes and accreditation / sector scheme non-conformities ensuring they are resolved using LR processes and timescales
- Support the training of assessors, technical reviewers and other parties to ensure that CPD, capability and compliance needs are met. When required provide technical expertise and advice to Training both External and Internal
- Within agreed authorised area of specialism and knowledge, undertake third party assessments in line with policy and objectives. The expectation is an average of 8 fee earning days per month.
- Interpret regulatory rules to ensure that technical decisions strike a balance between meeting client and business needs, and adherence to accreditation requirements, making recommendations for input into local and area operational strategies
- Establish and develop a commercial mind-set and culture through the leadership and coaching of the technical community to support business growth and diversity within management systems. Ensure adequate global communication is provided for the Clients to understand the regulatory requirements for the change from CMDCAS to MDSAP
- Monitor and review health and safety performance, observe safety behaviours in the workplace, taking appropriate corrective and preventive action as necessary and suggesting and implementing improvement activities.
- Degree or business qualification, with management experience within a technical area of specialism ideally across a geographic region
- Experience in providing technical support and advice within a technical and field assessment environment
- Experience in driving change, supporting risk management initiatives and building technology readiness being able to travel across the region and to meet area requirements
- Flexible and results-oriented approach to meet varying and competing client and business demands
- Experienced in developing, delivering and integrating technical processes, building and sustaining positive commercial and client relationships
- Possess effective business networks in the relevant industry and regulatory bodies that will impact the business operations. Have a high level of English both written and spoken
- An assertive approach to problem solving with strong communication and diplomacy skills to guide, negotiate, influence and persuade at all levels
- A wide breadth and depth of knowledge of project management with proven skills in dealing with medium to high complexity through the mentoring of direct and indirect team members
- Intrinsic dedication to safe working practises and a leading example of a mature safety culture.
- Experienced in development, delivery and needs based analysis of training requirements and processes ideally within an area / global environment is an advantage and using a variety of electronic media
- Technical Manager
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