(Senior) Regulatory Affairs Specialist

Demant Polska; Rosówek; Hybrid; PLN 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work model

Onboarding support

Global exposure

English-speaking environment

Job summary

DGS Diagnostics, based in Rosówek near Szczecin, invites a (Senior) Regulatory Affairs Specialist to join our international team and ensure our medical device products meet global regulatory requirements throughout their lifecycle.

You will work with colleagues across Europe, support MDR/FDA/ISO compliance, and contribute to labeling, IFU updates, and registrations, while enjoying a hybrid work model and English-speaking environment.

Qualifications

• Bachelor's or Master's degree in Life Sciences, Healthcare, Engineering, or a related field.
• Experience in Regulatory Affairs within medical devices or regulated environments.
• Knowledge of MDR, FDA requirements, and ISO standards.
• Professional proficiency in English, both written and spoken.

Responsibilities

• Ensure regulatory requirements are fulfilled for medical device products.
• Ensure design changes are properly managed and communicated according to regulatory requirements.
• Cooperate in RA Intelligence process, collecting and listing in newsletter & action log.
• Update country-specific details and regulatory information.
• Provide support during labeling and IFU creation/modification.
• Support organization (e.g. Customer Service and Technical Documentation) in relation to Regulatory Affairs issues.
• Ensure that we have a business behind all registrations (incl. re-registrations).
• Cooperate with notifying body and quality during audits.

Skills

Regulatory Affairs

MDR/ISO knowledge

English communication

Analytical mindset

Stakeholder management

Education

Bachelor's/Master's in Life Sciences/Healthcare/Engineering

Job description

At DGS Diagnostics, we develop advanced hearing diagnostic solutions used globally by healthcare professionals. From our office in Rosówek near Szczecin, you will work as part of an international team, partnering with colleagues across Europe and supporting products that improve people's quality of life. As a (Senior) Regulatory Affairs Specialist, you will play an important role in ensuring our products meet international regulatory requirements and remain compliant throughout their entire lifecycle.

Whether you already have solid experience in Regulatory Affairs or are looking to further develop your expertise within the medical device industry, this is an opportunity to work with innovative technologies, gain exposure to global regulatory requirements, and collaborate closely with your manager and key stakeholders across different locations.

Working with us you will receive:

• An international work environment built on trust, respect, and openness;
• A comprehensive onboarding program and support from your team from day one;
• Opportunities to continuously develop your expertise in Regulatory Affairs and the medical device industry;
• Exposure to global regulations and standards, including MDR, FDA requirements, and ISO standards;
• Collaboration with experienced professionals across Regulatory Affairs, Quality, R&D, Product Management, and Customer Service;
• Flexible working hours and a hybrid work model (minimum 3 days per week in the office);
• Daily use of English in an international setting;
• Full-time employment in a growing international organization and global market leader;
• The satisfaction of working on products that make a real difference in people's lives.

What tasks are waiting for you?

• Ensure that regulatory requirements are fulfilled for medical device products.
• Ensure the design changes are properly managed and communicated according to the relevant regulatory requirements
• Cooperate in RA Intelligence process, collecting and listing in newsletter & action log
• Ensure country specific details and info are updated
• Provide support during labelling and IFU creation/modification
• Support organization (e.g. Customer Service and Technical Documentation) in relation to Regulatory Affairs related issues;
• Ensure that we have a business behind all registrations (incl. re-registrations)
• Cooperate with notifying body and quality during audits.

It would be great if you have:

• A Bachelor's or Master's degree in Audiology, Healthcare, Life Sciences, Engineering, or another relevant scientific or technical field;
• Experience in Regulatory Affairs within the medical device industry or another regulated environment;
• Knowledge of medical device regulations, directives, standards, and guidelines such as MDR and ISO standards;
• Strong communication and relationship-building skills;
• An analytical mindset and attention to detail;
• Professional proficiency in English, both written and spoken;
• A proactive approach and willingness to learn and grow.

What will help you succeed in this role?

• Strong knowledge of regulatory requirements and their practical application within the medical device industry;
• Ability to balance compliance requirements with business needs;
• Excellent organizational skills and a structured way of working;
• Confidence in managing multiple stakeholders and coordinating activities across departments;
• Strong communication skills and the ability to work effectively in an international environment;
• A pragmatic, solution-oriented mindset and willingness to take ownership.

As a (Senior) Regulatory Affairs Specialist, you will work closely with Elena Tormen, your direct manager, based in Italy.

Interviews will be conducted on a rolling basis.

#DGSDiagnostics