Responsible Person (QP)

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Person Responsible for Regulatory Compliance (PRRC)

My client is seeking an experienced and dedicated Person Responsible for Regulatory Compliance (PRRC) to join their dynamic manufacturing team. In this critical role, you’ll be the expert of the medical device’s efforts, ensuring that their products meet the highest standards of safety, efficacy, and regulatory compliance.

Your Impact:

As our PRRC, you’ll be the cornerstone of our regulatory compliance framework. Your expertise will be crucial in:

* Ensuring full compliance with the EU Medical Device Regulation (MDR) and other relevant regulations

* Overseeing the implementation and maintenance of our quality management system

* Fostering a culture of continuous improvement in regulatory processes

* Serving as the primary point of contact for regulatory authorities Key Responsibilities:

1. Regulatory Mastery

* Stay ahead of changes in regulatory requirements and implement necessary updates

* Manage the preparation and submission of technical documentation and periodic safety reports

2. Quality Assurance

* Oversee the implementation of the quality management system

* Ensure product conformity checks are conducted before device release 3. Post-Market Surveillance

* Manage the post-market surveillance system

* Ensure timely reporting of serious incidents and field safety corrective actions

4. Complaint Handling

* Lead the investigation of complaints and reporting of incidents to authorities

* Implement appropriate actions in case of non-conforming devices

5. Continuous Improvement

* Identify opportunities for process enhancement in regulatory compliance and quality

* Drive projects aimed at optimizing regulatory processes

What You Bring To The Table:

* A degree in a relevant scientific discipline (e.g., Engineering, Natural Sciences, Medicine, Pharmacy)

* 3+ years of professional experience in regulatory affairs or quality management for medical devices * In-depth knowledge of EU MDR and other medical device regulations

* Strong understanding of quality management systems and risk management

* Excellent analytical and problem-solving skills

* Exceptional communication and leadership abilities

* A track record of successful regulatory interactions and audits

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.

Ryan Griffin

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