Job Description

Medical Affairs Specialist

The Medical Affairs Specialist is a global function dedicated to supporting the company's clinical activities and aligning with strategic goals to maintain high standards for patient safety and support regulatory obligations. The Specialist role plays a crucial role in identifying the clinical value proposition for innovative concepts. These activities demonstrate the company's commitment to containing and delivering injectable therapies that improve the health of patients worldwide.

This role plays a pivotal role in supporting clinical consultation and medical affairs activities within the development of medical products. This role bridges the gap between clinical practice and research, ensuring that medical device development are not only scientifically sound but also practically relevant and patient-focused.

The incumbent will collaborate with clinical teams, regulatory bodies and cross functional departments to support the smooth execution of risk evaluation, documentation and safety assessments. The role will also support clinical consultation and medical affairs by ensuring that clinical regulatory technical documentation, and testing validation are aligned with clinical work flow, real-world clinical practices and patient needs, ultimately enhancing the development of safe and effective medical products.

Essential Duties and Responsibilities

• Act as the primary liaison between clinical experts and cross functional teams (quality, operations, engineering, regulatory etc.), facilitating the exchange of clinical insights and literature research findings.
• Support the Medical Affairs team by providing detailed clinical insights and ensuring regulatory documentation address the practical needs of healthcare providers and patients.
• Assist in developing and executing Clinical Evaluation Strategies that integrate current clinical practices and methodologies.
• Contribute to the clinical literature search by providing insights into relevant clinical trends and findings.
• Collaborate with clinical teams to conduct formative and summative usability studies, supporting products needs for both clinicians and patients. Review and interpret usability study results from a clinical perspective, providing guidance on usability improvements.
• Participate in risk management activities, including dFMEA, uFMEA, pFMEA, URRA, and the development of risk management plans. Evaluate potential hazards and harms within clinical contexts to support robust risk mitigation strategies.
• Support the creation of clinical documentation to reflect up-to-date clinical practices and standards.
• Facilitate communication between the Medical Affairs team and other stakeholders, so that clinical insights are disseminated and integrated effectively across projects.
• Completes required administrative tasks within the specified timeframes.
• Performs related duties as assigned.

Basic Qualification

• PharmD, MD, Or RN degree required
• Minimum of 3 years clinical and/or hospital experience
• Minimum 5+ years of relevant medical experience

Work Experience

• Strong experience in of global regulatory (drug or device or combination products) and GxP guidelines.
• Must have excellent project management skills and excellent written and verbal communication skills
• Prior supervisory experience preferred and quality improvement or educational experience
• Strong experience in of global regulatory (drug or device or combination products) and GxP guidelines.
• Understanding and experience with the use and development of medical devices and combination products.

Preferred Knowledge, Skills and Abilities

• Hospital experience and working in the pharmaceutical/CRO industry preferred.
• Demonstrated ability to think critically and analytically
• Ability to work as part of a team as well as independently
• Aptitude for reviewing and understanding clinical trials protocol
• Ability to understand and interpret clinical literature (via medical journals, and resources like Medline, PubMed, etc.)
• Good knowledge of document management systems and relevant applications.
• Strong understanding of clinical practices and the ability to translate clinical needs into research objectives.
• Skill in managing consultations and clinical affairs activities, ensuring timely and effective execution.
• Ability to assess and integrate clinical data, research findings, and usability assessments into actionable strategies.
• Strong ability to work in multi-functional teams, bridging clinical practice and research.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws. By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.

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