Regulatory Affairs Specialist -Medical Devices
- Applications are considered on a rolling basis
- Multiple locations
- Remote
The Regulatory Affairs Specialist is responsible for preparing, submitting, and maintaining regulatory documentation to support global approvals of high-risk or implantable medical devices. This role ensures compliance with U.S. FDA regulations, EU MDR 2017/745, and other international requirements, supporting product lifecycle management from development through post-market surveillance.
Department: Regulatory Affairs
Reports To: Senior Regulatory Affairs Manager
Key Responsibilities:
- Prepare and submit regulatory documents such as IDEs, PMAs, PMA Supplements, Technical Documentation (per EU MDR), and global registrations (e.g., Canada, Japan, China, Australia).
- Ensure labeling, Instructions for Use (IFUs), and promotional materials meet regulatory requirements for Class III devices.
- Lead or support regulatory strategy development for new product introductions, design changes, and sustaining products.
- Maintain compliance with regulatory standards including FDA 21 CFR Parts 807, 812, 814, and EU MDR Annexes I–III, IX, X.
- Support the maintenance of Clinical Evaluation Reports (CERs), Risk Management documentation (ISO 14971), and Post-Market Surveillance (PMS) activities.
- Collaborate with cross-functional teams (R&D, Clinical, Quality, Marketing) to ensure regulatory requirements are met throughout the product lifecycle.
- Participate in internal audits, FDA inspections, and Notified Body assessments as the Regulatory SME.
- Monitor and communicate changes in global regulations and assess the impact on existing products and documentation.
- Maintain regulatory records, files, and tracking systems in accordance with company procedures and quality systems (ISO 13485, QSR).
Great Place to Work
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Flexible work model
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Work globally, hired locally
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Global environment
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Fast growing trajectory
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Career opportunities
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Fast paced & entrepreneurial culture
Skills & Requirements
Qualifications:
Required:
- Bachelor’s degree in Regulatory Affairs, Biology, Pharmaceutical, Life Sciences, or related field.
- 2+ years of regulatory affairs experience in the medical device industry, with at least 2 years supporting Class III devices.
- Strong working knowledge of U.S. FDA regulatory pathways (e.g., PMA, IDE) and EU MDR Technical Documentation requirements.
- Experience preparing regulatory submissions and responding to regulatory authority queries.
- Familiarity with ISO 13485, ISO 14971, and applicable international regulations (e.g., TGA, PMDA, NMPA).
- Strong project management, organizational, and communication skills.
Preferred:
- Experience with implantable devices.
- Experience with software used in documentation and submission preparation (e.g., regulatory databases).
Personality
- Independent: You are independent in organizing your daily tasks, able to manage your work in a remote setting.
- Detail-oriented and organized: Your work is highly organized and precise, with a keen attention to detail and a structured approach to every task to ensure compliance.
- Resilient and adaptable: You bring a resilient, can-do attitude and demonstrate persistence when facing challenges.
- Collaborative: You have strong interpersonal and communication skills to effectively collaborate with internal teams and external stakeholders
Work with great people
About the company
Nordberg Medical is a Swedish biotech company working at the forefront of biomaterial science to reverse functionality loss. With state-of-the-art biomaterials, we produce and market innovative medical products that target structural imbalances associated with aging.
In 2021, we passed a critical milestone by receiving CE certification for our first product. JULÄINE™ of Sweden is a biostimulator that activates natural collagen production in the skin. This positions the company well to pursue an ambitious growth strategy in the aesthetic dermatology market.
Backed by leading investors and extensive R&D, we are expanding across multiple therapeutic areas and geographies.
Join an international team of highly talented individuals where your contribution counts. We promote a culture of entrepreneurship, multiculturalism, and flexibility in more than ten countries. At Nordberg Medical, you will have the opportunity to grow and learn, to be creative, and to contribute to both our product and company success.
Add the title below:Our values
Ambitious- Self-drive supports the collective ambition of the company. - We are the front runners in next generation biomaterials. - We develop the business through continuously learning from our experiences. - We reward achievements and celebrate progress along the way. - We focus on the solution when faced with setbacks.
Unique- We transform the market with breakthrough innovation. - We prove uniqueness through science and outstanding partnerships. - We embrace differences as strengths by including different viewpoints in our business. - We encourage our teams to develop current business practices with innovative ideas.
Accountable- We put the customers at the core of everything we do. - We deliver on promise and communicate with honesty. - We take responsibility for all our actions and the resultant outcomes. - We recognise and embrace our responsibility for a positive impact on stakeholders and communities.
United- We achieve success through joint efforts and teamwork. - We develop partnerships through a strong belief in the product and mission. - We bridge differences by assuming good intent and acting in the best interests of each other.
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