Regulatory Affairs Officer – Praca – Poznań, Sady

Lina Medical; Poznań; Hybrid; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Private medical care

Sports card

Flexible schedule

Home Office

Holiday support

English classes

Snacks

Job summary

Lina Medical is seeking a Regulatory Affairs professional to manage registrations and renewals across markets, and to drive regulatory activities in line with global requirements.

You will review and update regulatory documents, assess changes, and liaise with authorities and customers. The role includes audits, project leadership, and lifecycle regulatory support in an international environment.

Qualifications

• Master’s degree in life science or technical field.
• 3+ years regulatory experience in the Medical Device or Pharmaceutical industry.
• Experience with Regulatory Authorities and EU registrations.
• Familiar with MDR 2017/745 and EN ISO 13485.

Responsibilities

• Manage product registrations and renewals on selected markets.
• Lead regulatory activities per local and international requirements.
• Review and update regulatory documents and product technical files.
• Review changes for regulatory compliance.
• Communicate with authorities and customers (distributors, health authorities).
• Support audits and contribute to improving the Quality Management System.

Skills

Communication skills

Regulatory knowledge

Interpersonal skills

Time management

Attention to detail

Analytical skills

English fluency

Education

Master's degree in life science/technical field

Job description

Responsibilities:

• Manage product registrations and renewals on selected markets;
• Lead and drive regulatory activities in accordance with local and international requirements;
• Responsible for review and update of regulatory documents, product technical files and for ongoing activities related to compliance with regulatory directives and regulations;
• Conduct reviews of product and manufacturing changes for compliance with applicable regulations;
• Review and approve Change Requests in accordance with regulatory requirements;
• Communicate with and maintain a positive business relationship with external customers from distributors to health authorities (FDA, Health Canada, Notified Body);
• Drive improvement in regulatory aspects of the Quality Management System and in documenting procedures to ensure an effective Quality System is maintained;
• Assistance with audits;
• Act as a Project Leader in diverse internal projects;
• Contribute to providing regulatory advice throughout the product lifecycle;
• Perform other tasks or assignments, as delegated by regulatory management;
• Supporting the Post-Market Surveillance (PMS) process ? creating, investigating, monitoring and maintaining;
• Provide regulatory support for clinical evaluation process.

Knowledge/experience:

• Master degree in life science / Technical discipline or relevant;
• Minimum 3+years regulatory experience in the Medical Device or Pharmaceutical industry;
• Previous experience working with Regulatory Authorities;
• Experience in registration of medical devices or pharmaceuticals in EEA and outside European Union;
• Familiar with MDD 93/42/EEC, MDR 2017/745, EN ISO 13485;
• Knowledge of standards and quality systems;
• Experience in auditing is an advantage.

Skills:

• Excellent verbal and written communication skills with ability to effectively communicate at multiply levels in the organization;
• Ability to prioritize and plan work activities in a fast-paced environment; adapt for changing conditions;
• Good interpersonal skills - ability to work both independently and as part of a team;
• Ability to handle multiple tasks and to prioritize/schedule work to meet business needs with routine supervision;
• Attention to details, quality and accuracy;
• Effective analytical/problem solving skills;
• Fluent in English (oral and written);
• Ability to analyse and resolve non-routine regulatory issues using independent judgment.

We offer:

• Full-time job contract;
• Opportunity to work in an international environment;
• A number of benefits (private medical care, sports card, flexible working time, Home Office, co-financing of holidays, co-financing for English language classes, fruit and snacks);
• Great atmosphere in the office and interesting challenges;
• Opportunity to grow with the organization and build a successful career path;
• Internal and external training.