The clinical Safety Manager, champions product safety through involvement in post-market surveillance, risk management, clinical support and education.
As a Safety Manager
- Maintains thorough knowledge of the science of wound healing in order to be an educated resource in products and treatment innovations in the health care industry. Advise Global KCI team members regarding questions and issues with wound care therapies, product knowledge, and product development.
- Develops risk assessments for innovation projects, including risk benefit analysis, residual risk, safety review of post marketing data and literature reviews.
- Contributes to the update and development of clinical guidelines for company’s products.
- Actively participates in Health Hazard Assessment/Evaluations and Corrective Actions related to marketed products.
- Collaborates in the post marketing surveillance activities providing/ supervising clinical review of safety data for AWT products.
- Provides authorship to the risk/benefit analysis of AWT products as required
- Conducts reviews of safety information as needed and contribute to the content of the product labeling by incorporating product safety knowledge (gained through interactions with the product users).
- Supports KCI internal training, the Training and Education Center, and Sales and Marketing groups by providing clinical expertise, knowledge and experience on all KCI products.
- Responds to safety, clinical and usage queries received from internal and external customers via clinical calls or emails
- Reviews accuracy of the clinical and safety content of literature (GMAAP and CRAS reviews), including communications to internal and external customers, regarding KCI therapies, product evaluation and data conclusions.
- Collaborates with other groups in the KCI Medical division, Marketing, Regulatory Affairs, Research & Development, Legal, labeling and Quality Assurance on various projects.
Skills and Experiences:
- Ability to handle the complexity of multiple projects
- Strong communication skills
- Must be highly proficient in the use of Microsoft Office suite (especially Microsoft Word and PowerPoint); skill in Microsoft Excel.
- Expert knowledge of clinical research, scientific method, device development processes, regulatory requirements, good clinical practices and basic understanding of statistical methods.
- Ability to interpret and organize scientific data
- Bachelors Degree in Nursing
- 2+ years work experience in the the medical device or related industry.
- 2+ years research experience
- Experience in risk management of medical devices.
- Wound Management Experience
- Risk assessment experience
- Experience with Advance Wound Healing (AWT) products
- Knowledge of EU MDR
Bachelors Degree in Nursing or higher.
The information listed above is not a comprehensive list of all duties/responsibilities performed.
This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice.The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf VEVRAA Federal Contractor