Regulatory Affairs Specialist US
- Applications are considered on a rolling basis
- Multiple locations
- Remote
The Regulatory Affairs Specialist US is responsible for preparing, reviewing, and maintaining regulatory submissions and documentation required for U.S. FDA approvals of high-risk and Class III implantable medical devices, including degradable and bioabsorbable implants. The role focuses on ensuring compliance with FDA regulations and supporting product lifecycle management from development to post-market activities.
This position collaborates closely with global Regulatory Affairs colleagues, project managers, and cross-functional teams to drive efficient regulatory submissions and ensure continued compliance with US-marketed devices.
Key Responsibilities
Your responsibilities will include, but not be limited to:
- Prepare, review, and submit U.S. regulatory documentation, including Investigational Device Exemptions (IDE), Premarket Approval Applications (PMA), PMA Supplements, and 510(k) submissions.
- Evaluate and confirm completeness and accuracy of technical and clinical documentation to support U.S. registrations
- Collaborate with global RA colleagues to align submission strategies and documentation.
- Support discussions with CROs, external consultants, and FDA representatives, leveraging internal and external networks, in collaboration with our Global Regulatory Strategy Director and Senior Regulatory Affairs Manager.
- Review labeling, IFUs, and promotional materials for compliance with U.S. regulations.
- Ensure regulatory compliance with FDA 21 CFR 807, 812, 814 and applicable guidance for PMA and 510(k) submissions.
- Participate in audits and FDA inspections as a Regulatory Affairs subject matter expert.
- Monitor changes in U.S. regulatory requirements and assess potential impact on products and documentation.
- Maintain accurate regulatory records and tracking systems in compliance with ISO 13485 and internal quality system procedures.
Skills & Requirements
Education: Bachelor’s degree in Regulatory Affairs, Biology, Biomedical Engineering, Life Sciences, or related field.
Experience: Around 3–5 years of regulatory affairs experience in the medical device industry, specifically working with degradable implants. Preferably in aesthetics injectables or orthopedics. Furthermore, you have experience:
- Preparing, reviewing, and submitting regulatory documentation and responding to FDA inquiries.
- Using regulatory information management systems or submission tools.
- Working with CROs or external partners for regulatory submissions.
Knowledge: Strong understanding of U.S. FDA regulatory pathways, including either PMA or 510(k) processes. If you have worked with both – that's highly beneficial.
Familiarity with ISO 13485, ISO 14971, and FDA Quality System Regulations (QSR).
Personality
- Adaptable and growth-minded: Embraces learning opportunities and contributes to a positive, solutions-focused team culture.
- Detail-oriented and structured: Ensures high accuracy and compliance in documentation and submissions.
- Collaborative communicator: Works effectively with cross-functional teams and global colleagues.
- Independent and proactive: Able to organize and manage work with minimal supervision, including in a remote setting.
Other information
This is a full-time, remote-based position located in the United States. The role requires a willingness to travel within the U.S. with occasional travel to Europe. Employment will be through Nordberg Medical (US) Inc.
Please note that candidates must be legally authorized to work in the United States. We are unable to provide visa sponsorship for this position.
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.
Yuting (Carmen) Zhu | Contact Person
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