Medical Affairs, Medical Device Operations Lead

 

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Medical Affairs, Medical Device Operations Lead 

 

Responsible for global medical and scientific expertise regarding the product portfolio (device and/or digital) and to engage with R&D. Also responsible for supporting regional MA colleagues, notified body audits, educational content creation, and collaborate with marketing and strategy teams related to the product portfolio and clinically relevant expertise areas.

 

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Medical Affairs, Medical Device Operations Lead, are to:

 

• Leads the creation, support, and management of notified body related medical affairs activities such as, CERs, PMCF, PSURs, etc.;
• Consolidates existing medical-scientific expertise & activities between global product experts;
• Completes evidence gap identification and support the publication planning, and opinion leader development with the relevant product teams and stakeholders;
• Improves the dialogue, information exchange and alignment between global/regions/countries;
• Member and medical lead for device development projects/studies within Product Squads;
• Co-develops, with product teams educational materials and content for both internal and external stakeholders;
• Ongoing lifecycle support for license to market;
• Co-Leads the risk assessment for devices, provides health risk assessments (HRA) as required;
• Lead/support aspects of global projects and adapt product offerings to critical industry trends and competitive activity with support from senior MA medical device/SaMD leaders;
• Contribute to the continued execution of medical affairs as an industry leading organization.

 

WHO YOU ARE

 

Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

• Advanced Degree with clinical experience or a Bioscience/engineering degree with relevant experience in the medical device area;
• Relevant experience with medical device development;
• Deep knowledge in FDA, EU, ICH, and Notified Bodies guidelines, initiatives and regulations governing medical devices & SaMD;
• Medical device experience supporting the creation of educational content;
• Ability to support the development of  studies and build evidence generation plans;
• Must exhibit the capability to work collaboratively with management and peers to assess, evaluate and implement business strategies aligned with global or appropriate regional activities;
• Strong communication and interpersonal skills and the ability to drive measurable outcomes with virtual teams;
• Desire and ability to work in a fast growing, agile business environment;
• Willing to travel internationally to global meetings and international congresses;
• Good medical writing skills and ability to analyze safety data;
• Good communication skills;
• Fluent in English, both written and spoken.

 

Preferred Qualifications:

• Medical qualification as MD or equivalent (D.O., M.B.B.S, etc.), preferred;
• 2-3+ years industry experience;
• Exposure to artificial intelligence/machine learning applications in Radiology is a plus.

 

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