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Senior Medical Devices Safety Specialist
@Anteristech
[Hiring] Senior Medical Devices Safety Specialist @Anteristech
Mar 26, 2025 - Anteristech is hiring a remote Senior Medical Devices Safety Specialist. 💸 Salary: competitive compensation package, including salary and bonuses. 📍Location: USA, Australia, Switzerland.
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Role Description
We are seeking a Medical Safety Specialist to play a crucial role in monitoring, assessing, and ensuring the safety of our biomimetic TAVR valve throughout its lifecycle. The Clinical Safety Specialist role will collaborate with multidisciplinary teams to mitigate risks, address safety concerns, and contribute to post-market surveillance efforts.
- Continuously monitor, collect, and review adverse event reports, malfunctions, and other safety-related data for the biomimetic TAVR valve.
- Prepare and submit timely, accurate safety reports to regulatory bodies in accordance with global regulations.
- Develop, implement and manage study-specific Safety Management Plan (SMP) and Case Report Forms (e.g., AE, DD/DM, and Adjudication CRFs) and associated Charters.
- Review draft informed consent forms (both templates and site-specific), ensuring they include all required elements, are written in plain language, and are tailored to the specific study and participant population, while also adhering to relevant regulations and guidelines.
- Issue and resolve safety queries in the study database.
- Manage activities related to study committees (CEC, DSMB/DMC, Independent Medical Monitor) or oversee third party management of committee activities per study SMP and associated Charters.
- Manage accurate and timely safety related regulatory reporting (AEs, SAEs, UADEs) per study and regulatory requirements, including collaboration with regulatory affairs and clinical operations, or overseeing activities of third-party managing safety reporting.
- Collaborate with the clinical and engineering teams to identify potential risks associated with the device.
- Lead post-market surveillance activities, ensuring prompt identification and investigation of any potential safety concerns.
- Act as a safety liaison between the company and clinicians, ensuring they are adequately informed about the safe and effective use of the device.
- Stay up to date with local, national, and international regulations and standards related to medical device safety.
- Maintain meticulous records of all safety data, investigations, and reports.
Qualifications
- Bachelor's degree in a relevant field (e.g., Nursing, Healthcare and Lifesciences, Biomedical Engineering, Pharmacy) required. Advanced degree preferred.
- Minimum of 5 years’ experience in medical device safety.
- Requires a minimum of 5 years’ experience implementing safety processes in medical device clinical trials.
- Experience managing and executing processes for CEC and DSMB/DMC.
- Knowledge of global medical device regulations and standards (e.g., FDA, EU MDR, ISO 13485).
- Excellent analytical and problem-solving skills.
- Strong written and verbal communication abilities.
- Ability to work in a fast-paced environment and manage multiple priorities.
Benefits
- Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
- Collaborative and dynamic work environment with a culture of innovation and excellence.
- Competitive compensation package, including salary, performance-based bonuses, and stock options.
- Career development opportunities and a chance to be part of a growing company that values its employees.
- Medical, Dental, and Vision Offerings.
- Flexible Spending Account (FSA).
- 401k + Company Match.
- Life, AD&D, Short Term and Long-Term Disability Insurance.
- Bonus Plan Eligibility.
- Employee Stock Option Plan.
- Paid Holidays & Vacation.
- Employee Assistance Program.
- Inclusive Team Environment.
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| 📍 | Be aware of the location restriction for this remote position: USA, Australia, Switzerland |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
Back to Remote jobs >
All others
All others
|
Salary
💸
competitive compensation package, including salary and bonuses
|
Remote
Location
USA, Australia, Switzerland
|
|
Job Type
full-time
|
Posted
Mar 26, 2025
|
️
| 📍 | Be aware of the location restriction for this remote position: USA, Australia, Switzerland |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
