Developing global clinical affairs strategies, in close collaboration with regulatory affairs, marketing, research & development, reimbursement, and outcomes planning, and obtaining approvals by the most effective method possible.

Ensuring organizational readiness for submitting applications for product approval by regional regulatory bodies (EU, FDA, PMDA a.o.).

Developing and executing the Clinical Affairs Strategy to generate data for both marketing and regulatory purposes.

Enrolling and managing KOL / physician-clinician engagement and leading the management of all Clinical Affairs investments and required support.

Executing studies in the US, EU and Asia in full compliance with all applicable GCP requirements, regulations, and standards.

Collaborating with Regulatory Affairs and R&D to strategize best effective approaches to clinical study designs and execution to support regulatory approval.

Approving contracts and budgets with sites, CRO’s and vendors.

Taking responsibility for data collection, analysis, and presentation to company management.

Managing the preparation of data for publication, white papers, presentations, etc. .

Preparing and approving of protocols for projects and reviewing final study conduct documents such as study manuals, study plans, study tools, etc..

Developing staffing plans according to needs.

Initiating investigator and coordinator meetings.

Participating in Risk management and R&D DRs representing clinical affairs.

Providing oversight of individual clinical trials to ensure full compliance with GCP and that safety concerns and/or adverse events are identified and appropriate responses to such concerns are executed.

Providing advice to the customer complaint reportability team of adverse events and other clinical trial issues to regulatory agencies.

Determining membership criteria and identifying potential members for clinical events committees and data monitoring committees.

Reviewing and approving trigger plans for CEC and DMC.

Reviewing and approving Clinical Risk-Benefit Analyses.

Reviewing and approving study corrective action plans.

Preparing for and participating in internal/external study-related audits.

Developing and maintaining Clinical Investigation,conduct infrastructure – drafting and/or reviewing of SOPs, DOPs, and Work Instructions.

Demonstrating thorough knowledge of and coaching others in the appropriate application of clinical research conduct, laws, regulations, standards, and compliance with applicable SOPs and policies.

Maintaining familiarity with global medical device regulations and national certification schemes.

Participating in requested meetings and Trade Shows (demo equipment on the show floor, participate in wet lab events), etc.

Participating in professional organizations or conferences to keep abreast of developments in the relevant fields of medical devices.