EU MDR Regulatory Lead — Medical Device Technical Files

BVI Medical, Inc.; Polska; Sur place; PLN 180 000 - 260 000; Plein temps

Résumé du poste

BVI Medical, Inc. is seeking a Senior Regulatory Affairs Specialist to prepare gap assessments and update product technical documentation to meet EU MDR requirements.

The role interfaces with Medical Affairs, Regulatory Affairs, R&D, Quality Engineering and Manufacturing to support compliance and business continuity. The candidate will collaborate with MDR project teams, ensure alignment of documentation timelines, and participate in regulatory impact assessments related to MDR, engaging

Qualifications

• Minimum of a bachelor’s degree in Mechanical, Electrical, Biomedical Engineering or other scientific discipline.
• Minimum of 5 years of experience in Regulatory Affairs in an FDA or ISO regulated environment.
• Experienced in the preparation of EU MDR product technical documentation.

Responsabilités

• Review gap assessments on Product Technical Files against MDR requirements.
• Review all technical documentation (design verification & validation protocols, risk management, usability, etc.).
• Support data collection for submissions to EUDAMED and MDR program timelines.
• Interact with Notified Body reviewers and auditors during reviews.
• Identify regulatory obstacles and propose solutions for MDR compliance.
• Support product labeling and promotional materials review relevant to MDR registration.
• Assist new product development with MDR data collection for submissions.
• Adhere to Company policies and ethics.

Connaissances

Regulatory affairs

EU MDR

Medical device compliance

Documentation review

Formation

Bachelor's degree in Mechanical/Electrical/Biomedical Eng or related field

Outils

Regulatory submissions tools

Description du poste

Purpose

Join our international Regulatory Affairs team, based remotely in Poland, and support global projects across Europe. In this role, you will work primarily on new product development and regulatory compliance, supporting product portfolios across BVI’s international business.

You will work with colleagues across Regulatory Affairs, R&D, Quality, Medical Affairs and Manufacturing, with a particular focus on EU MDR requirements, Technical Documentation and product compliance.

This is a great opportunity to join a global team, work on new product projects and gain exposure to international regulatory activities - all while working fully remotely from Poland, with no travel required.

The expected salary is approximately PLN 18,000 gross per month.

Key Responsibilities

• Support new product development projects by providing Regulatory Affairs input and ensuring regulatory requirements are considered throughout the product lifecycle.
• Review and maintain Technical Documentation to ensure compliance with EU MDR 2017/745 and applicable regulatory requirements.
• Conduct gap assessments and identify regulatory risks, working with cross-functional teams to address gaps and develop appropriate solutions.
• Support regulatory compliance activities across BVI’s product portfolio, including assessment of applicable standards and General Safety and Performance Requirements.
• Collaborate with international teams across Regulatory Affairs, R&D, Quality, Medical Affairs and Manufacturing, supporting projects across Europe.
• Interact with Notified Bodies during Technical Documentation reviews, audits and regulatory discussions, where required.
• Support regulatory submissions and documentation activities, including EUDAMED and Declaration of Conformity requirements.
• Provide regulatory guidance to project teams, helping ensure timely completion of regulatory activities and supporting business continuity.
  
  

Qualification

• 5+ years of Regulatory Affairs experience within the medical device industry or another highly regulated environment.
• Strong practical knowledge of EU MDR 2017/745 and medical device regulatory requirements.
• Hands-on experience preparing, reviewing or maintaining Technical Documentation / Technical Files.
• Experience supporting new product development and regulatory activities throughout the product lifecycle.
• Experience with regulatory compliance, gap assessments and applicable medical device standards.
• Experience working cross-functionally with teams such as R&D, Quality, Manufacturing, Medical Affairs and Regulatory Affairs.
• Strong analytical and problem-solving skills, with the ability to work independently and identify and address regulatory issues.
• Bachelor’s degree or equivalent in Engineering, Biomedical Sciences, Life Sciences, Regulatory Affairs or another relevant scientific/technical discipline, with fluent professional English.
  
  

Company

BVI® is refocusing the future of vision.

As one of the fastest-growing, diversified surgical ophthalmic businesses in the world, our purpose-built portfolio of trusted brands includes: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs), and spans more than 90 countries.

We’ve set our sights on touching the lives of millions of patients affected by conditions such as cataracts, refractive error, glaucoma, retinal disease, and dry eye. Unburdened by legacy or bureaucracy, we have developed our strategy around a simple concept – taking pride in delivering innovative solutions for our physicians and patients, based on their needs. We trust and empower our associates to make decisions and solve problems because collaboration drives us. Valuing agility, simplicity, and transparency, we stay committed to listening to our customers, delivering for our patients, and keeping the future in focus.

Learn more at www.bvimedical.com