Medical Device/SaMD Medical Affairs Device Lifecycle

Bayer•Indiana Township, PA

7h•Onsite

About The Position

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 Device/SaMD Medical Affairs Device Lifecycle Responsible for global medical and scientific expertise regarding assigned product portfolio (device or digital) and to engage with R&D, RM, QA, etc. as per lifecycle and lifecycle NPD needs. Also responsible for supporting regional MA colleagues and collaborate with marketing and strategy teams related to assigned product portfolio and clinically relevant expertise areas. This opening is site based working form our Indianola/Pittsburgh, PA work location. A US Residence based option may be available for the selected Candidate. YOUR TASKS AND RESPONSIBILITIES The primary responsibilities of this role, Medical Device/SaMD Medical Affairs Device Lifecycle, are to: Consolidates existing medical-scientific expertise & activities between global product experts; Co-develops/aligns global medical strategy for the relevant brands; Completes evidence gap identification, publication planning, and opinion leader development; 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 marketing, the integrated brand strategy; Ongoing lifecycle support for license to market; Co-Leads the risk assessment for devices, provides health risk assessments (HRA) as required; Contribute to the global communication strategy and campaigns, reflecting disease management as applicable to devices or SaMDs; 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 development and execution of congress strategy and global standards development. WHO YOU ARE Bayer seeks an incumbent who possesses the following: Required Qualifications: Medical qualification as MD or equivalent (D.O., M.B.B.S, etc.), or a Bioscience/engineering degree with relevant experience in the medical device area; Relevant experience with medical device development initial knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing medical devices & SaMD; Medical device experience supporting the development of brand plans, marketing campaigns and related content or other relevant marketing experience; 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 writing skills and ability to analyze safety data; Good communication skills; Fluent in English, both written and spoken. Preferred Qualifications: Clinical experience is an advantage; 2-3+ years of experience with medical device development initial knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing medical devices & SaMD. Employees can expect to be paid a salary of between $180,400.00 to $270,600. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors. This posting will be available for application until at least: 2-4-2026. #LI-US YOUR APPLICATION Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Health for all, Hunger for none, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer. To all recruitment agencies: Bayer does not accept unsolicited third party resumes. Bayer is an Equal Opportunity Employer/Disabled/Veterans Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below. Bayer is an E-Verify Employer. Location: United States : Pennsylvania : Indianola || United States : Pennsylvania : Pittsburgh || United States : Residence Based : Residence Based Division: Pharmaceuticals Reference Code: 860632 Contact Us Email: [email protected]

Requirements

Medical qualification as MD or equivalent (D.O., M.B.B.S, etc.), or a Bioscience/engineering degree with relevant experience in the medical device area
Relevant experience with medical device development initial knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing medical devices & SaMD
Medical device experience supporting the development of brand plans, marketing campaigns and related content or other relevant marketing experience
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 writing skills and ability to analyze safety data
Good communication skills
Fluent in English, both written and spoken

Nice To Haves

Clinical experience is an advantage
2-3+ years of experience with medical device development initial knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing medical devices & SaMD

Responsibilities

Consolidates existing medical-scientific expertise & activities between global product experts
Co-develops/aligns global medical strategy for the relevant brands
Completes evidence gap identification, publication planning, and opinion leader development
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 marketing, the integrated brand strategy
Ongoing lifecycle support for license to market
Co-Leads the risk assessment for devices, provides health risk assessments (HRA) as required
Contribute to the global communication strategy and campaigns, reflecting disease management as applicable to devices or SaMDs
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 development and execution of congress strategy and global standards development