SciPro continues our long-standing exclusive partnership with a ground-breaking, medical device company who are the creators of an award-winning AI-powered imaging biomarkers and software solution. They are passionate about becoming a leader in the precision medicine space, enabling better treatment decisions for patients. We are supporting the company on their search for a Regulatory Affairs Specialist within the UK. As a Regulatory Affairs Specialist, you will be responsible for supporting global regulatory activities, ensuring products remain compliant across both EU and US regulatory frameworks. Working closely with cross-functional teams, you will help drive regulatory strategy, support product lifecycle changes, and ensure regulatory requirements are embedded across the organisation.Key Responsibilities Support FDA submissions, ensuring regulatory documentation is prepared accurately and delivered on time.Manage product changes across EU and US markets, ensuring all updates remain compliant with applicable regulatory requirements.Oversee post-market surveillance activities, monitoring product performance and ensuring ongoing regulatory compliance. Key Requirements Experience as a Regulatory Affairs Specialist or Senior Regulatory Specialist.Strong understanding of regulatory compliance for SaMD or IVD products.Experience working within EU and/or US regulatory frameworks.

B2B Sales Lead (Permanent) – Medical Device Industry A growing medical device company is seeking a permanent B2B Sales Lead to drive commercial growth and expand its presence in the German and broader European healthcare market. You will lead and execute the B2B sales strategy, focusing on hospitals, clinics, distributors, and healthcare partners. This role combines strategic planning with hands-on business development and key account management. Key Responsibilities Develop and implement the B2B sales strategy Identify and acquire new healthcare and distribution partners Manage and grow key accounts across Germany and selected EU markets Lead contract negotiations and close high-value deals Build and mentor a small sales team (as the function scales) Collaborate with marketing, regulatory, and product teams to align go-to-market activities Represent the company at industry events and trade fairs Profile Proven B2B sales experience within the medical device or healthcare sector Strong network within hospitals, clinics, or healthcare procurement Demonstrated success in driving revenue growth Excellent negotiation and stakeholder management skills Based in Berlin or willing to relocate Fluent in German and English

 Position Summary We are seeking a Combination Product Manager, R&D to support the development of drug-device combination products. This role is responsible for managing product design, risk management, and regulatory documentation. The position will work closely with internal teams and external partners to ensure products are safe, effective, and compliant.Reporting Structure This role reports to the Executive Director, External R&D and works with Quality, Regulatory, Clinical, Supply Chain, and external design firms, manufacturers, and suppliers. Key Responsibilities Support the design and development of drug-device combination products using design control processes Prepare, review, and maintain Design History Files (DHF) and risk management documentation Work with external partners to review product designs and development progress Provide technical support for combination products such as injectors, inhalers, transdermal systems, and infusion devices Ensure documentation meets regulatory and quality requirements Support product risk assessments, complaint investigations, and product improvements Partner with Quality and other teams to maintain compliant product files Stay current with regulatory requirements and industry standards Qualifications BS or MS in Mechanical Engineering, Chemical Engineering, or related field 5–7 years of experience developing drug-device combination products Experience with design controls and risk management Experience with Design History Files (DHF) preferred Strong communication and technical writing skills Ability to work independently and work with cross-functional teams

Responsibilities: Support product release activities in compliance with FDA QSR and ISO 13485Author, execute, and review validation documentation (IQ/OQ/PQ, process and packaging validations)Prepare and maintain controlled engineering documentation, protocols, reports, and change recordsSupport sterile barrier system validation activities, including seal strength, integrity, and package performance testingCollaborate cross-functionally with Quality, Manufacturing, and Regulatory teams to ensure release readiness Qualifications: Bachelor’s degree in Engineering3+ years of experience in a regulated medical device environmentHands-on experience with validation and controlled documentationFamiliarity with thermoforming and package sealing processes is a strong plusExperience supporting packaging process validation and product release activities