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Senior Manager

1 month ago

Rotherham South Yorkshire, United Kingdom CSG Talent Full time €70,000

Interim) Senior QA/RA Manager (Global) Up to £70,000 basic, bonus and benefits
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 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.

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
Experience in managing a Quality system, ISO compliance and audits
Understand LEAN concepts, methodologies and deployment would be beneficial

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