Regulatory Affairs Manager to Nordberg Medical AB

Nordberg Medical AB is a Swedish MedTech company based in the Karolinska Science Park, Stockholm. The company is committed to the development, manufacturing, marketing, and sale of high-end medical devices that focus on cutting-edge biomaterials. Nordberg Medical AB is the daughter company of a global leader in the development and production of medical grade polylactic acid, that has among its shareholders leading PE and VC investors. With strong R&D resources, Nordberg Medical is poised to expand into multiple lines of medical device products covering fields such as aesthetics, orthopaedics, trauma surgery, sports medicine, neurosurgery, and plastic surgery.

Nordberg Medical AB passed a significant milestone in 2021 by receiving CE certification for its PLLA (Poly-L-Lactic Acid) based collagen stimulant, JULÄINE™, positioning the company well to pursue an aggressive growth strategy for the aesthetic dermatology market.

Nordberg Medical AB has also initiated an FDA application that will support entry into the US and additional key markets.

About the position
As a Regulatory Affairs Manager, you will be responsible for identifying and implementing the regulatory strategy to commercialize the company’s product portfolio worldwide. You will work closely with CROs to implement the strategy as soon as possible.

Key Responsibilities:

• Plan and coordinate regulatory affairs in the US market, as well as other key international markets, such as Latin America, Asia, and the Middle East. This includes new product registrations.
• Plan, coordinate and execute, together with external consultants, the company’s EU MDR application via a Notified Body.
• Coordinate with the management of the company, on registration priorities, strategies, and the preparation and scoping of related documentation and studies.
• Coordinate price submissions to the different price databases when that is needed.
• Partner with potential regulatory and market access experts to understand the best route to market from a regulatory point of view.
• Handle new product introductions, calling in appropriate technical support as needed.
• Liaise regularly with the R&D team to understand what is needed to meet customer and regulatory demand.
• Awareness of regulatory environments and what is needed to go to market.
• Work with the CEO and COO to develop market entry strategies from a regulatory point of view.

Your profile
The suitable candidate has the following qualifications:

• At least a bachelor’s degree in a life-science discipline.
• Multiple years of experience in regulatory affairs within medtech and/or pharma.
• Ability to learn new product areas from both scientific and medical perspectives.
• Established networks within relevant industries.
• Well versed in the various relevant regulatory frameworks in Europe and the US.
• Fluency in English. Other language(s) are highly advantageous.
• The ideal candidate for this position is driven, well organized and has a strong ability to build effective relationships with colleagues and collaborators.
• Strong communication and time management skills as well as excellent problemsolving skills are required to be successful in this role.
• Excellent attention to details and enjoys working in a dynamic work environment.

Working and employment conditions:
With our priority on productivity and communication, we take a flexible approach to working location. In consultation with senior management, the successful candidate will be able to combine working remotely and from the company’s headquarters in central Stockholm. Regular attendance for group meetings is required.
The position will be full-time employment, with terms and conditions fully respecting all Swedish laws and regulations. Core to Nordberg’s mission is to be a stand-out employer.