Regulatory Affairs Specialist

Bellman & Symfon; Göteborgs kommun; On-site; SEK 502,200 - 725,400; Full time

Job summary

Bellman & Symfon in Gothenburg is seeking a Regulatory Affairs Specialist for a 12-month temporary contract. The role involves monitoring international regulatory requirements and ensuring compliance throughout product lifecycle.

The ideal candidate will have a university degree in a relevant field, proficiency in Swedish and English, and demonstrated experience in regulatory affairs. You will work in a collaborative environment contributing to products that improve lives.

For applications, please submit your CV and cover letter as applications are reviewed continuously.

Qualifications

• University degree in a relevant field such as Science, Engineering, Medicine, or Law.
• Professional proficiency in both Swedish and English, written and spoken.
• Experience in project management and owning specific project deliverables.

Responsibilities

• Monitor and assess international regulatory requirements.
• Provide regulatory guidance throughout the product lifecycle.
• Execute project regulatory planning activities, including documentation submissions.
• Support reviews of Product Technical Documentation.
• Prepare and maintain regulatory records.
• Lead implementation of new and revised regulations.

Skills

Project management

Professional proficiency in Swedish

Professional proficiency in English

Attention to detail

Collaborative teamwork

Education

University degree in Science, Engineering, Medicine, or Law

Job description

Are you passionate about regulatory compliance and medical device regulations? Do you thrive in a collaborative, international environment where your expertise helps bring innovative products to global markets? If so, we invite you to join the Quality & Regulatory team at Bellman & Symfon Group as a Regulatory Affairs Specialist on a 12-month temporary contract.

At Bellman & Symfon, we develop solutions that empower people who are deaf or hard of hearing to live safer, more independent, and socially active lives. As part of our global team, you will play a key role in ensuring regulatory compliance for the products we design, manufacture, and distribute worldwide.

The Role

As Regulatory Affairs Specialist, you will be responsible for monitoring and assessing international regulatory requirements and supporting regulatory planning activities for new and existing products, market segments, and regulatory changes in accordance with the Group Regulatory Plan.

You will provide regulatory guidance throughout the product lifecycle - from design and development to manufacturing and distribution - ensuring products are released to market in compliance with applicable regulations.

This role offers the opportunity to work in a global context alongside engaged colleagues and cross-functional teams. You will report directly to the Group Chief Quality & Regulatory Officer (GCQRO).

Key Responsibilities

Your responsibilities will include, but are not limited to:

• Execute project regulatory planning activities, including preparation and submission of documentation, information, and data required for product registrations across global markets.
• Support reviews of Product Technical Documentation to establish regulatory evidence, including:
  • Product Risk Assessments
  • Labelling and Instructions for Use
  • Clinical Evaluations
  • Post-Market Surveillance
  • Vigilance activities
• Prepare, maintain, and update regulatory records, including:
  • Harmonized Standards and Guidance Lists
  • General Safety and Performance Requirements (GSPR)
  • Declarations of Conformity
• Assess new and revised regulations and lead their implementation in an effective and timely manner.
• Support the organization with regulatory compliance guidance throughout product development, manufacturing, and distribution processes.

Qualifications and Experience

Required Qualifications

• University degree in a relevant field such as Science, Engineering, Medicine, Law, or equivalent.
• Professional proficiency in both Swedish and English, written and spoken.
• Experience of project management, and owning specific project deliverables.

Regulatory Affairs Experience

You have demonstrated experience in Regulatory Affairs and a strong understanding of:

• Medical device regulations and quality management system standards.
• Product development and regulatory approval processes in both the EU and USA.
• Product registrations, regulatory submissions, and maintenance of regulatory filings within established timelines.
• Clinical Evaluations and/or Clinical Investigations.
• Post-Market Surveillance and Vigilance activities.

Who You Are

To succeed in this role, you are:

• A collaborative team player who enjoys working across functions and cultures.
• Quality-driven with a strong attention to detail.
• Solution-oriented and proactive in addressing regulatory challenges.
• Customer-focused with a commitment to delivering compliant and effective products.

We offer an engaging workplace, supportive leadership, and motivated colleagues who are passionate about making a difference. If you are looking for an opportunity to further develop your regulatory affairs career while contributing to meaningful products that improve lives, we would love to hear from you.

How to Apply

If you are excited about the opportunity to make a meaningful impact and contribute to innovative solutions that improve people's lives, we would love to hear from you. Please submit your CV and cover letter as applications are reviewed on a continuous basis, so we encourage you to apply as soon as possible.

Questions?

For more information about the role or Bellman & Symfon Group, please contact:

Oscar Sedström
Group Chief Quality & Regulatory Officer
Phone: [phone]
Email: [e-mail]

About Bellman & Symfon

Founded in Gothenburg, Sweden, in 1989, Bellman & Symfon develops innovative solutions that help people who are deaf or hard of hearing stay safe, independent, and socially active.

Our global headquarters are located in Gothenburg, Sweden, and we are supported by regional offices and a trusted partner network across Europe, Asia‑Pacific, and North America.

For more information, visit www.bellman.com.