Lead Specialist Post-Market Surveillance (Remote)

Cordis

4d • Remote

About The Position

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care. At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients. If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you. We are the people behind the people who keep saving lives.

Requirements

• Required Qualifications Requires a minimum 8+ years of relevant experience with a Bachelor's degree; or equivalent education and experience; Or 6+ years and a Masters degree;Or a PhD with 3+ years experience; or equivalent experience.
• Where required, the role must hold an appropriate degree in the industry (eg. Legal)

Responsibilities

• The candidate will be working cross-functionally and will collaborate with internal stakeholders, to include Clinical Affairs, Professional & Clinical Education, Regulatory Affairs, Quality Systems, Marketing, Sales as well as external stakeholders, to include FDA, NB, PMDA, KOL, HCP, IRB and publishers.
• The candidate should have a strong background in the clinical evaluation process, with a track record of successfully managing the remediation of medical devices from MDD to MDR using various clinical evaluation strategies.
• This individual will need to stay current on the changing requirements and guidances from the Notified Bodies, particularly BSi, and the ideal candidate will have experience working through NB deficiencies to conclusion. Experience with NB audits would also be ideal.
• Additional responsibilities include providing input to product development and post-market sustaining core teams.
• This individual will have visibility to senior leaders and needs to be comfortable presenting program updates using PowerPoint over Zoom or in person.
• This role will require training on the Cordis product portfolio and a baseline understanding of the therapy and disease states is preferred .
• Execute general medical writing, editing, and proofreading activities and systematic literature reviews for assigned CER projects
• Develop CEPs, CERs, PMCF plans and evaluation reports, and SSCP reports in accordance to EU MDR requirements
• Responsible for developing high quality surveys and executing them successfully
• Perform periodic reviews of risk documentation, product labeling, and marketing claims as part of the clinical evaluation process.
• Be a key collaborator with the biostatistics and data management team for complete results interpretation and to ensure the delivery of accurate and relevant output
• Represents the Clinical/Medical Affairs function and Clinical Evaluation Team on the EU-MDR Core Team(s), working closely with Core Team Leads on timelines and clinical needs.
• Ensure documents are produced in accordance with standard operating procedures, internal and external guidelines (e.g., MDD and MDR), and company templates
• Communicates with stakeholders and obtains stakeholder alignment to ensure business objectives are met
• Contributes to the strategic approach for the team's clinical evaluations with consideration of the portfolio-level view of other strategic approaches and NB feedback.
• Assist in developing and implementing corporate procedures for medical and regulatory writing
• Assist research and other project team members in additional responsibilities as required
• Support Quality audits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees