Vigilance Specialist

Location Brazil
Discipline: Regulatory Affairs
Job type: Fixed Term Full Time
Job ref: 003266
Published: 24 days ago
Startdate: 06-15-2023

Rayner is a leading developer and manufacturer of ophthalmic implants and pharmaceuticals with global headquarters in Worthing, UK. We specialize in the design and manufacture of intraocular lenses (IOLs) and related products, such as OVDs and pharmaceuticals used in cataract and refractive surgery. Since the manufacture of the world’s first IOL by Rayner in 1949, we have continuously pioneered IOL design with a goal of improving vision and restoring sight worldwide. The first ever FDA- approved IOL was a Rayner lens. Today, over 26 million IOLs are implanted around the world every year, and it is globally the most performed elective surgical procedure. Our mission is simple: to deliver excellent visual outcomes for patients and surgeons.

Since Rayner was founded in 1910, we have established a reputation for innovation and product excellence. Rayner has over 500 employees in the UK, Germany, Austria, Switzerland, Spain, Portugal, Italy, France, Poland, US, Canada, Malaysia and India. We will continue on our exciting path of fast growth globally.

 

The Vigilance Specialist is second in command to the Vigilance Manager and is responsible for the implementation and management of a globally compliant medical device vigilance system encompassing complaint management, medical device reporting, field safety corrective action and post-market surveillance (PMS Plans and PSURs).

 

Your key responsibilities will be:

*  Creation, management, and update of post-market surveillance and vigilance required reports, including but not limited to PMS Plans (PMSPs), Periodic Summary Update Reports (PSURs), Annual Summary Reports for Canada, Australia and others as required.

*  Ensuring compliance with ANVISA reporting requirements including remaining up to date with legislation, preparation and submission of adverse event reports and liaising with the Health Authority

*  Preparation of data relating to the vigilance system to be used in product risk management.

*  Preparation of data relating to the vigilance system to be used to support new and/or renewed global registrations.

*  Preparation of data relating to the vigilance system to be used in Clinical Evaluation Reports, Technical Files or other company required data packages (e.g., Biological Evaluation Report).

*  Preparation of data relating to the vigilance system specific to direct markets to better aid the Commercial Team’s understanding of events in certain territories (e.g., UK, USA, global).

*  Receiving, recording, evaluating, investigating, and processing of all complaints involving Rayner products that have been placed on the market.

*  Submission of medical device incident reports to global National Competent Authorities (NCAs).

*  Product return inspections (comprising of evaluation of contaminated product returns associated with vigilance cases and testing where possible).

*  Ensure compliance to internal SOPS and external regulations/standards.

*  Support activities of the vigilance team to help ensure that all stakeholders (company staff, distribution partners, end users, etc.) are suitably trained and aware of the requirements of the Vigilance system appropriate to their role.

*  Assist in the creation and update of vigilance procedures and associated forms.

*  Assist in the management of field safety actions, including but not limited to, sending customer notifications, submitting field safety corrective action reports to global NCAs, product reconciliation and answering requests from NCAs.

*  Participate in internal and external audits and other inspections.

*  Participate in other company processes as a Vigilance SME where required e.g., non-conformance, CAPA, Risk committee.

*  Assist the Vigilance Manager to ensure we remain up to date with applicable regulatory and legislative requirements and developments relating to Vigilance.

 

Ambition: We play to win.

Focus: We put patients first.

Integrity: We keep our promises.

Openness: We are passionate about new ideas.

Respect: We support each other.

 

Competencies

 

  • Excellent written and verbal communication skills.
  • Strong decision-making and problem-solving skills.
  • Experienced in the establishment and maintenance of a medical devices vigilance system.
  • Proficient in medical devices vigilance standards and regulations.
  • Patient safety focus
  • Statistical analysis

Either:

*       Qualification in a science, clinical or engineering subject

*       1-2 years’ experience in a Quality or Regulatory role in a medical devices or pharmaceutical company

*       Familiar with Quality System concepts, practices, and procedures (e.g., ISO 13485, CFR820)

 

Desirable:

*       Some knowledge of the requirements of a medical device vigilance system.

*       Experience working across export markets and dealing with international distributors.

*       Direct interaction with regulatory authorities (Notified Bodies, Competent Authorities, Government Agencies etc).

*       Prior statistical analysis experience.