ReCor Medical is looking to recruit a Manager or Director of Clinical Safety & Regulatory Compliance responsible for the UK and EU. Working closely with the Global Clinical Safety team and the Global Regulatory team (both headquartered in Palo Alto, CA, USA) this role will report directly to the VP, Regulatory & Medical Affairs.
The Manager/Director, Clinical Safety & Regulatory Compliance will be responsible for the management and oversight of clinical safety activities (clinical medical device vigilance), including the reporting of safety events in the EU/UK for a Global Clinical program. They will be responsible for communications with EU/UK regulatory authorities and will provide regulatory document support, as needed, to ethics committees, competent authorities and notified bodies. They may also be involved in clinical and quality audits of investigational sites and vendors.
Overview of Duties & responsibilities:
- Support timely reporting of all applicable safety events to EU/UK regulatory authorities
- Support timely submission of all clinical regulatory documents to ethics committees and regulatory authorities as required.
- Contribute to the development of a global safety database.
- Collaborate with study Clinical Site Managers and Clinical Research Associates to ensure comprehensive safety information is available and translated for full review, coding and reporting.
- Ensure timely reporting in compliance with MEDDEV regulatory guidance documents.
- Collaborate with the Global Clinical Safety team on the coding of adverse events in an electronic database system with query generation as needed; and query reconciliation through partnering with the Clinical Affairs team and the study sites.
- Assist with new clinical study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.
- Support clinical and vendor audits
- Maintain clinical regulatory documents, monitor and recommend improvements.
- Generate safety reports for regulatory agencies including Clinical Evaluation Report and Annual Safety Reports.
- Participate in DSMB and CEC, as needed
- Evaluate clinical data and contribute to annual, interim and final reports of clinical information.
- Participate in protocol review for future studies for safety input including requirements of a CEC or DSMB, adverse event reporting requirements and endpoint determination.
- Participate in the formulation of case report forms for future studies, specifically with regards to reporting and management of adverse events.
- Support clinical procedure training as needed.
- Quality-focused. Ensure protocol compliance, facilitation of data collection and source document verification and compliance. Continuously evaluate, recommend and implement quality improvements as needed.
- Independent and proactive personality; able to think critically and create customer-based solution.
- Ability to demonstrate competence and credibility to build relationships of trust with DSMB, CEC, CROs, physicians, statisticians and research staff at clinical sites.
- Position requires cross-functional collaboration with Clinical Affairs, Biostatisticians & Data Management, R & D and Quality.
- Minimum of a Bachelors’ degree, health related or other scientific discipline; Advanced degree (MD, DVM) preferred.
- Minimum of 3-5 years cardiovascular industry experience.
- Minimum 3-5 years global clinical trial experience.
- Knowledge of clinical trial and regulatory process required, including FDA, ICH, MEDDEV Guidance and ISO Regulatory Processes.
- Ability to work cross-functionally and across time zones.
- Strong verbal and written communication skills.
- Self-motivated with excellent time management skills.
- Fluency in English is required, any other European language is an asset.
Attractive compensation package, commensurate with experience..
Interested applicants should send a covering letter and a copy of their CV to firstname.lastname@example.org or contact Jane Gregory on +44 1304 806862.