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(Interim) Senior QARA Manager
4 months ago
(Interim) Senior QA/RA Manager (Global)
Up to £70,000 basic, bonus and benefits
Based: South Yorkshire (hybrid role)
CSG are proudly and exclusively partnering a growing and already highly successful medical equipment/devices group, urgently and looking for an International QA/RA Manager…a role that genuinely boasts superb career development and growth opportunities as well (especially over the first 12-24 months).
As a QARA Manager you will be part of a lean business with a blend of intelligent, committed, and down to earth individuals. As an effective member of the local management team, you will be engaged in long-term strategy, regulatory strategic decision-making operations, and bringing novel medical products to new markets in a compliant manner.
The QARA Manager organises, plans, directs, and controls all Regulatory Affairs and Quality Assurance functions including product registration, complaint handling and reporting, internal and external auditing of the quality systems and supports R&D and Marketing. Develops policies, procedures, and training to ensure efficient and effective operation of the Company quality system and regulatory requirements. Serves as the Quality Assurance Management Representative and Medical Device Person Responsible for Regulatory Affairs.
The QARA manager will also be responsible for spearheading the creation, implementation, and oversight of our company's Environmental, Social and Governance (ESG) policies and initiatives. The role will involve collaborating with various stakeholders to ensure alignment with industry standards, regulatory requirements, and corporate objectives. You will also monitor and evaluate the effectiveness of our ESG strategies to drive continuous improvement and enhance our overall sustainability performance.
Requirements:
- Bachelor's degree, preferably in Regulatory Affairs and/or a science related field
- A successful track record in Quality and Regulatory compliance in SME environment
- A minimum 5 years of professional experience in quality and/or regulatory areas in medical devices or similar products (EU MDD/MDR, US FDA class II/III)
- Experience in the regulation and introduction of connected devices and the quality and regulatory compliance surrounding the introduction of software solutions
- Currently working in medical device/equipment business with an awareness of wider healthcare sector and its associated regulations
- Must have personal "hands on" experience with successful preparation, submission of CE & UKCA marking / technical files experience, 510(k) experience would be beneficial
- Experience in supporting international registrations, clinical investigations and clinical evaluation reports
- Experience in managing a Quality system, ISO compliance and audits
- RAPS RAC preferred
- Understand LEAN concepts, methodologies and deployment would be beneficial
If the above description and outline meets your experience and sounds of interest please apply and we will be in contact to discuss. Please note if you do not fit the above criteria we cannot consider you for the role and though you will receive a courteous response unless you again fit the requirements we will not be able to progress with your application.
CSG are an equal opportunities working on behalf of the client.
