Job Title: Specialist, Medical Affairs – Physician (Medical Device)
Location: United States (Remote)
Department: Medical Affairs
Employment Type: Full-Time
About the Role:
We are seeking a Specialist Physician to join our Medical Affairs team, contributing medical expertise to support regulatory, scientific, and promotional activities for medical devices. The role ensures the accuracy, integrity, and compliance of medical content, while responding to inquiries from internal and external stakeholders including Clinical R&D, Safety, and Commercial teams. The Specialist Physician also participates in the development and implementation of medical and clinical program strategies.
Primary Responsibilities:
Provide medical expertise and scientific clarification as needed.
Participate in literature reviews and interpret clinical study data in collaboration with Regional and Global Medical Affairs and Clinical R&D.
Identify potential medical issues and implement risk management strategies.
Support the development of medical strategies for assigned medical devices.
Advise commercial, marketing, and sales teams on medical content.
Develop and review medical materials for congresses, symposia, advisory boards, and publications.
Assist in updating materials in response to new scientific literature, media coverage, marketing initiatives, product recalls, or medical discoveries.
Develop and review medical training programs for new and existing employees.
Ensure the accuracy of product information manuals, FAQs, labeling, packaging components, and compendia.
Participate in cross-functional teams to ensure promotional and non-promotional materials maintain medical and scientific accuracy.
Support preparation of periodic safety reports, regulatory submissions, PSURs, annual reports, and CCDS.
Secondary Responsibilities:
Plan and delegate tasks to meet project deadlines efficiently.
Mentor junior team members and support functional capability development.
Ensure quality, compliance, and timeliness in all deliverables.
Conduct functional and technical training sessions for the team.
Maintain compliance with QMS/ISMS & PIMS policies and report any security incidents.
Contribute to achieving quality objectives and performance goals.
Qualifications & Experience:
MD in Cardiology (aligned with project and business team requirements).
Minimum 5–7 years of relevant experience in medical affairs, clinical research, or medical device domain.
Strong understanding of regulatory, clinical, and medical communication standards.
Proven ability to collaborate cross-functionally, mentor teams, and deliver high-quality scientific content.
Excellent communication, analytical, and problem-solving skills.
Why Join Us:
This role offers the opportunity to contribute directly to medical device strategy and patient outcomes, working remotely while collaborating with a global team of medical and clinical experts. You will support scientific excellence, regulatory compliance, and innovation in medical affairs, while growing your professional career.
Equal Opportunity Statement:
We are an equal opportunity employer and value diversity and inclusivity in the workplace. All qualified applicants will receive consideration without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status.
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