Vacant job

Orkla Health, Wound Care, develops, manufactures, and markets consumer products within wound care and first aid for both workplaces and industrial customers. The company has a strong tradition of its own product development and innovation and has played an important role in shaping the category of consumer wound care and first aid. Well-known brands within the category include Salvequick, Salvelox, and Norgesplaster in the B2C segment, as well as Cederroth First Aid and Snögg in the B2B segment.

Within the Wound Care category, approximately 35 people work at the office in Solna, where a total of approximately 220 employees work within Orkla's different product segments, with leading positions in the Nordic region and a strong international presence.

About the Role

In the Regulatory & Quality group (R&Q) within Orkla Health, Wound Care category, a total of 9 people work, of whom 4 are based at the office in Solna. The group supports all functions of the organization with expertise in regulatory requirements for medical devices and other market-relevant requirements.

In the role of Regulatory Specialist, you contribute to all parts of the work. You work both independently and in projects with colleagues within the company. The heart of the role is to ensure compliance with all applicable regulations for products on the market.

As a project participant, you ensure that regulatory requirements are identified and integrated effectively into product development and launch processes. You also contribute to ensuring that products meet market requirements throughout their lifecycle.

The work involves close collaboration with product development, manufacturing, and colleagues within your own department, and you work extensively with digital tools and systems.

Your responsibilities include but are not limited to:

• Ensuring regulatory compliance on domestic and international markets for medical devices throughout their lifecycle.

• Creating, maintaining, and reviewing technical documentation, as well as artwork and marketing materials in accordance with regulatory requirements.

• Working with risk management according to ISO 14971.

• Product registration on relevant markets.

• Searching and collecting information in relevant databases.

• Collaborating with the team to handle communication with authorities, notified bodies, and respond to inquiries, inspection requests, and follow-up actions.

• Participating in cross-functional projects with representatives from product development, marketing, quality, and manufacturing to support product development, support regulatory processes, and ensure that regulatory requirements are met.

Your Profile

The right candidate has the ability to prepare clear, concise regulatory documentation (e.g., registrations, technical files, and risk assessments), has a strong eye for detail, excellent communication skills, and a structured approach.

You are comfortable performing interpretations and assessments in the regulatory landscape and have the experience to work in accordance with regulations, as well as a knack for working in various software and databases. Your attention to detail does not hinder your flexibility, and you thrive in a dynamic environment, working curiously and proactively, thereby driving your commitments forward.

To thrive in this role, you should be able to exercise self-leadership and be comfortable working autonomously under personal responsibility.

Qualifications:

• An academic degree in Life Science (e.g., Toxicology) or a corresponding field.

• Substantial experience (at least 3 years) in regulatory or related work within medical technology or in vitro diagnostics (IVD).

• Good knowledge of the Medical Devices Regulation MDR (EU 2017/745) or IVDR (EU 2017/746), with experience in areas such as:

  • Risk management.

  • Clinical evaluations and/or biocompatibility and toxicology.

  • Post-Market Surveillance (PMS) / follow-up of registered products.

• Knowledge of standards such as ISO 14971, the ISO 10993 series, and ISO 13485.

• Good proficiency in creating, maintaining, and reviewing technical documentation.

• Experience in leading and documenting risk assessments.

• Experience with sterile medical devices and regulatory work related to Canada, USA, and MDSAP is an advantage.

• Fluent knowledge of at least one Scandinavian language as well as English, both spoken and written.

We Offer

• An exciting and development-oriented workplace with the opportunity to influence and develop future medical devices.

• An engaged and supportive team that enjoys working together.

• Modern facilities and a flexible working approach with some possibility to work from home.

Contact

In this recruitment process, Orkla Health category Wound Care collaborates with SallyQ. We receive applications until May 31st. For questions, do not hesitate to contact Ellinor Crafoord, Recruitment Consultant at SallyQ, [email protected], 0793554257.

Application

Does this sound like a role for you? Please submit your application; we look forward to reading it.

About Orkla Health

Orkla Health is a leading Nordic brand company within consumer health, with strong positions in Omega-3, wound care, and oral care. With exports to over 25 markets outside Europe and distribution in more than 60 markets globally, we generate an annual turnover of approximately 6 billion NOK.

Orkla Health has a commercial presence in the Nordic countries, the Baltic states, and Poland, as well as representation in several additional countries. Our products are sold through pharmacies, grocery retail, directly to consumers, and through contract manufacturing.