обновлено 1 месяц назад
Post Market Surveillance (PMS) Specialist - Medical Devices
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Post Market Surveillance (PMS) Specialist - Medical Devices (Medical Devices): Evaluating vigilance data, adverse events, recalls, FSCA obligations, and post-market clinical follow-up documentation with an accent on international regulatory requirements, risk assessment, and benefit-risk evaluation. Focus on reporting adverse events, updating PMS and vigilance procedures, conducting literature reviews, and coordinating responses to authorities and customers.
Location: Hybrid in Berlin, Germany. The role requires legal eligibility to work in Germany and willingness to travel to locations, business contacts, conferences, and trade shows.
Company
develops precision engineered components and subsystems for healthcare and advanced manufacturing, including technologies for minimally invasive surgery, robotics, and 3D metal printing.
What you will do
- Evaluate adverse events using event descriptions and medical device investigation results.
- Determine reporting obligations and submit adverse event reports according to international and country-specific regulatory requirements.
- Search and assess vigilance data, support risk and benefit-risk assessments, and contribute to health-risk assessments.
- Determine recall and FSCA obligations and create the related documentation.
- Act as a point of contact for regulatory authorities and customers regarding vigilance matters.
- Maintain vigilance SOPs and update PMS and PMCF documentation in line with MDR, MDCG, MDSAP, and other regulatory requirements.
Requirements
- At least one year of professional experience reporting adverse events to regulatory authorities.
- Experience in risk assessment and the medical device or another regulatory environment.
- Knowledge of international vigilance requirements, vigilance database management, and benefit-risk evaluation.
- University degree in life sciences, natural sciences, or an equivalent qualification.
- General QMS knowledge, strong documentation skills, and the ability to coordinate complex workflows systematically.
- Fluent written and spoken English and legal eligibility to work in Germany are required.
Nice to have
- Experience in literature searches and reviews.
- Knowledge of regulatory medical writing.
- German language skills.
Culture & Benefits
- Collaborative and empowered global working environment.
- Interaction with international stakeholders, regulatory authorities, customers, and business contacts.
- Opportunities to attend conferences and trade shows.
- Work connected to medical technologies that support patient outcomes and minimally invasive surgery.
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