Regulatory affairs director Jobs in Bordesholm

CRA II or SCRA (ideally with minimum of 3 years experience of monitoring) based in Germany or other environs. Is capable of conducting SIVs, IMVs and COVs independently.

Has a solid working knowledge of the regulatory environment : ISO, MDR and GCP.

Is familiar with maintaining ISFs and the study e TMF.

Background in pharma or medical devices.

Experience in cardiology / cardiac therapy clinical trials.

Ideal locations : North or Central Germany

Responsible for remotely supporting field clinical research associate / site activities to ensure the overall integrity of study implementation and adherence to study protocol at assigned clinical sites.

Key Responsibilities :

• Organizing and supervising clinical study :

o Assist and conduct Clinical Monitoring activities

o Serve as key contact to assigned clinical sites throughout the study process

o Is accountable for achieving and reporting on agreed clinical milestones

o Supports study team in the interactions with Ethics Committees and Competent Authorities

o Participates actively to project team meetings, as required

o Close collaboration with internal stakeholders to ensure proper project conduct

o Assist in Providing site and Edwards personnel training including preparation / maintenance of study documents, completion of forms, understanding of examinations / assessments required

o Reporting site enrollment progress including device accountability and protocol deviations (inclusion / exclusion criteria, sequential enrollment) 6. Collecting completed Case Report Forms (CRF) and collecting, confirming and auditing supporting documentation.

o Document procedural case observations for insights in investigating post procedural events

o Data review, safety reporting and complaint handling

o Identifying and reporting adverse events and device-related complications in accordance with regulatory and internal requirements

Education and Experience :

Bachelor's Degree in in related field ,3 years experience of previous related medical device and / or clinical experience Required

Other : Clinician experience in intra-operative procedures acquired from Registered Nursing Degree curriculum (RN), or in positions such as Radiologic Technologist (RT), Operating Room Technician (ORT), or Cardiovascular Technician (RCIS) Preferred and

Other : Experience in interventional cardiology or cardiothoracic surgery Preferred

Additional Skills :

What is it like to work at Edwards Lifesciences in Germany?

As a global leader in patient-focused medical innovations, we offer rewarding opportunities and exciting challenges in a truly international, dynamic and friendly work environment.

We are committed to fostering a diverse and inclusive work environment where all employees can grow, personally and professionally. To achieve this, we offer on-the-job development, training opportunities and the support and guidance provided by dedicated employee groups (the Edwards Network of Women, Edwards Foundation charity team, sustainability activities, and others).

Edwards Lifesciences in Germany also offers the following benefits :

Benefits are regulated by an internal policy which contains the full details regarding the entitlement and conditions for the benefits. Benefits policy and components may vary by location.