Post Market Surveillance Lead (Remote)

The Post-Market Surveillance (PMS) Lead will be responsible for leading and executing post-market surveillance activities as per Medical Device Regulation (MDR) to ensure the continued safety and efficacy of iSTAR Devices. This includes gathering, analyzing, and reporting data on product performance and any incident, as well as ensuring regulatory compliance with relevant health authorities. The PMS Lead will lead cross-functional teams such as Quality Assurance, Regulatory Affairs R&D, Clinical and Medical department to implement effective post-market strategies and continuous product improvement.

Post-Market Monitoring & Reporting:

o Lead the design and execution of post-market surveillance programs for monitoring product safety, performance, and customer satisfaction.

o Collect and analyze post-market data (e.g., adverse event reports, product complaints, field data).

o Manage the reporting of incidents, FSCA and or product recalls to regulatory bodies as required by law (e.g., FDA, EMA, MHRA).

Incident Complaint Management:

o Promptly managed client feed back and complaints and internal investigation

o Develop corrective and preventive actions (CAPAs) when necessary, based on post-market data.

Risk Management:

o Collaborate with regulatory, R&D, medical and quality teams to ensure risk management files are maintained and updated

o Continuously evaluate product risk-benefit profiles post-launch and recommend to the management the necessary actions to mitigate potential risks.

Data Analysis & and Report Writing

o Analyze post-market data to identify trends or safety signals and present findings to senior management.

o Prepare and submit together with Regulatory Affairs detailed reports to regulatory bodies and maintain clear, up-to-date documentation of all post-marketing activities.

o Work with product development and quality assurance teams to drive product improvements based on PMS findings.

Regulatory Compliance:

o Ensure all PMS activities comply with applicable local and international regulations (e.g., FDA, CE Mark, ISO 13485, MDR).

o Coordinate with internal stakeholders (Regulatory Affairs, Quality Assurance, R&D) and ensure appropriate communication with regulatory authorities regarding post-market findings and actions.

o Stay updated on evolving regulatory requirements for post-marketing surveillance and ensure the organization is compliant

Training & Development:

o Develop and deliver training programs on post-market surveillance and product safety for internal staff.

o Ensure cross-functional teams are aware of their roles and responsibilities in the post-market phase.

Profile:

Education

• Bachelor’s or Master’s degree in a relevant field (e.g., Life Sciences, Biomedical Engineering, Public Health, Pharmacy, Regulatory Affairs).

Languages

• Fluent in English, written and spoken. Knowledge of French is beneficial

Professional Experience

• Minimum of 5 years of experience in PMS, regulatory affairs, or quality management in medical devices, pharmaceuticals, including report writing.
• Strong knowledge of PMS regulations and requirements (e.g., FDA, ISO 13485, EU MDR).
• Knowledge/understanding of statistics

Personal Skills

• Can be “hands on”
• Strong analytical skills with the ability to interpret complex data and identify safety signals.
• Knowledge of risk management principles, adverse event reporting, and product safety standards.
• Excellent communication skills, both verbal and written, with experience presenting findings to regulatory agencies and senior management.
• Proficiency in PMS-related software and databases.
• Detail-oriented with strong organizational skills.
• Ability to work collaboratively with cross-functional teams.
• Problem-solving mindset with a proactive approach to risk management.
• Assertive and independent thinking
• Can impactfully interact with broader range of stakeholders.
• Strong understanding of regulatory environments and product life-cycle management.

Offer:

We offer a full-time permanent position along with attractive remuneration packages and the unique opportunity to join a start-up with the potential to become a future key player in MIGS market today.

This position can be based remotely and depending on the location, we can offer either a permanent contract or a contractor agreement.

Headed by a solid management team, you will be part of a highly skilled (engineers, scientists) capable and dynamic team of innovative leaders with proven track records in the pharmaceutical and medical device industries.

We have an agile start-up company culture focused on values of entrepreneurship, engagement, integrity, passion and excellence.