Head of Regulatory & Quality Affairs

Biocool AB

Sweden - Stockholm

Apply now Be the Regulatory Anchor in a Fast-Growing Innovation Company
Biocool & BIOpH+ is a Swedish company creating consumer goods within the healthcare, hygiene, and cleaning industries, with a dynamic and fast-evolving product portfolio spanning biocides, medical devices, and cosmetics. Biocool & BIOpH++ is seeking a Head of Regulatory & Quality Affairs to take a strategic leadership role in driving product development and regulatory excellence. PharmaRelations is proud to support Biocool in the recruitment of this critical, full-time permanent position.

In this strategic key role, you will act as a bridge between R&D, manufacturing, and regulatory authorities, ensuring that Biocool’s & BIOpH++´s product pipelines are compliant, efficient, and innovative. You will also lead dialogue with customers and partners, ensuring trust in Biocool’s products and processes as they are marketed and sold globally.

We are looking for an extrovert and highly driven leader with commanding presence and charisma, who takes clear ownership of Regulatory Affairs (RA) and Quality Assurance (QA), demonstrates decisiveness, and naturally takes space in an entrepreneurial environment. You thrive in ambiguity, know what needs to be done, and drive initiatives forward with clarity and energy.

Location: Stockholm, Sweden, office-based position

Employment Type: Full-time

Industry: Medical Device | Cosmetic | Chemicals| Consumer products

Your New Job
You will own and develop our regulatory and quality strategies, ensuring compliance from concept to commercialisation. As part of the leadership team, you will work closely with product development teams and manufacturing partners, both in Sweden and internationally.

Key Responsibilities

• Lead regulatory strategy and execution for new product development across biocides, medical devices, and cosmetics.
• Actively support R&D teams from early concept through design, testing, and regulatory submissions.
• Work actively with creating claims and communication in guidance by consumer needs and regulatory requirements.
• Partner with internal and external manufacturing sites to ensure compliant scale-up, quality assurance, and smooth market release.
• Ensure compliance with EU regulations (e.g., MDR, BPR, EC 1223/2009) and applicable international standards.
• Maintain and evolve our Quality Management System (QMS), including ISO 13485 and GMP-related practices.
• Manage product registration, labeling compliance, claims substantiation, and post-market surveillance.
• Interface with regulatory authorities, notified bodies, and third-party consultants.
• Build and lead a growing RA/QA function as the company scales.

Extra merits

• Experience with BPR (Biocidal Product Regulation) and national registration of Biocide products.

Requirements

• 7+ years of experience in regulatory and quality affairs, preferably across medical devices, chemical products and/or cosmetics and consumer products.
• Strong background in working with product development and/or technical product teams.
• Strong communication skills both internal and external.
• Experience of registration of products on the international market.
• Experience in acting as the Person Responsible for Regulatory Compliance.
• Capability of navigating hands-on actions and sense on delegation or support from other experts are needed.
• Comfortable managing interactions with third-party manufacturers and navigating tech transfer processes.
• In-depth knowledge of EU regulations (MDR, BPR, Cosmetics Regulation).
• Experience with QMS, audits, and regulatory submissions.
• Excellent collaboration, leadership, and communication skills.
• Fluent in English (Swedish is an advantage).

What Biocool & BIOpH+ Offers

• Be part of an ambitious global growth journey.
• Play a key role in shaping strategic decisions at a fast-growing company.
• Collaborate closely with R&D, operations, and commercial teams.
• Contribute to bringing safe, compliant, and impactful products to market.
• Enjoy a flexible work culture with the opportunity to build and lead your own team over time.

The Recruitment Process - Your Application
PharmaRelations is managing this recruitment on behalf of & BIOpH+. If you believe your background and expertise align with the requirements, we encourage you to submit your application through the “Apply” button. All applications will be reviewed with great care as we seek the right candidate for this role. Please note that application documents should not be sent via email. For questions regarding the position, you are welcome to contact Kristina Edholm ([email protected]).