Sunmedic AB jobb

Sunmedic is a medical device company focused on developing safe and effective products. We are looking for a hands-on Regulatory Affairs Expert who can take ownership of technical documentation, ensure regulatory compliance, and work closely with quality and development teams. What you will do - Prepare, maintain, and update technical files and regulatory documentation in line with EU MDR and other applicable regulations. - Handle regulatory submissions (EU MDR) and manage lifecycle activities including updates and variations. - Support and maintain the quality management system (ISO 13485), including quality control documentation and records. - Review and assess design changes, labeling updates, and material changes for regulatory impact. - Collaborate with Quality Assurance and R&D teams to ensure technical documentation is complete, accurate, and audit-ready. - Prepare for and support audits and inspections by notified bodies and competent authorities. - Contribute to post-market surveillance activities and the preparation of related reports (e.g., PMCF, PSUR). - Monitor regulatory updates and implement necessary changes in technical files and quality documentation. Who you are - A practical and detail-oriented regulatory professional who enjoys working directly with technical files and documentation. - Comfortable working in a fast-paced environment where you need to deliver concrete regulatory outputs. - Proactive in identifying compliance gaps and implementing practical solutions. - Clear communicator who can work effectively with Quality, R&D, and external auditors. What you have - Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field. - At least 2 years of ,hands-on regulatory affairs experience, in the medical device industry. - Solid experience preparing and maintaining, technical files, and working within a quality management system (ISO 13485). - Good knowledge of EU MDR requirements and regulatory submissions. - Strong organizational skills and attention to detail when managing documentation and multiple tasks. - Proficiency in English (written and spoken). Nice to have: - Experience with post-market surveillance and clinical evaluation reports. - Familiarity with US FDA 510(k) or UK MDR submissions. - Previous involvement in audits or inspections. What we offer - Competitive salary and benefits. - Flexible working arrangements. - The opportunity to work closely with product development and quality teams on real regulatory deliverables. How to apply Please send your CV and a short cover letter describing your experience with technical files, quality systems, and regulatory submissions, to [email protected]. Mention any specific documentation or projects you have worked on.

About Sunmedic Sunmedic is a forward-thinking medical device company dedicated to delivering innovative, safe, and effective products for patients. We’re seeking a results-driven Marketing Specialist to join our team and help grow our brand, generate demand, and support product launches across markets. This role offers the opportunity to shape go-to-market strategies, collaborate with cross-functional teams, and play a pivotal role in bringing life-saving devices to patients. What you’ll do Develop and execute integrated marketing campaigns across digital and traditional channels to drive product awareness and demand. Collaborate with Product manager, Sales, Regulatory, and Medical Affairs to create compelling messaging, positioning, and value propositions for target segments. Manage content creation (website, blogs, case studies, brochures, social media) and lifecycle activities aligned with product launches and lifecycle management. Plan and optimize digital marketing efforts (SEO/SEM, social media, analytics) to achieve lead generation and pipeline goals. Analyze market trends, customer insights, and competitive landscape to inform strategy and tactics. Support events, webinars, and trade shows; coordinate collateral and speaker opportunities. Measure, report, and optimize campaign performance with clear KPI dashboards. Ansvara för marknadsstrategi: ta fram och driva marknadsstrategi och handlingsplan för tillväxt, i linje med bolagets mål Marknadsplan och genomförande: planera, prioritera och följa upp aktiviteter (kanalstrategi, kampanjer, lanseringar) Marketing av nya sårvårdsprodukter: ta huvudansvar för planering och genomförande av marknadsaktiviteter kopplade till nya produkter (go-to-market, lanseringsplaner, kampanjer och material) Kommersiell utveckling: bidra till mål för pipeline/leadsgenerering, försäljningstillväxt och ökad marknadsandel (tillsammans med distributörer) Segment och målgrupper: utveckla segmentering och säkerställa att budskap och erbjudanden matchar behov hos relevanta målgrupper Varumärke och positionering: säkra att varumärkesplattform och kommunikation är konsekvent och tydlig Ensure regulatory and compliance: Ensure brand consistency and adherence to regulatory/compliance considerations in marketing materials. Marknadskunskap och analys: följa marknadsdata, kundinsikter och konkurrensläge samt omsätta detta i förbättringar Budget och KPI:er: ansvara för marknadsbudget samt rapportera KPI:er och resultat (ROI, leadflöden, konvertering, aktiviteter som ger effekt) Samordning internt: nära samarbete med produktion, kvalitet/QA, logistik, produktutveckling och ledning för att säkerställa att marknadens planer är genomförbara och i rätt kvalitet Who you are A creative, data-driven marketer with a growth mindset and a collaborative approach. Strong storyteller who can translate complex medical device value into clear, compelling messaging. Results-oriented with excellent project management and prioritization skills. Comfortable working in a fast-paced environment and cross-functional teams. Clear communicator with the ability to engage both technical and non-technical stakeholders. What you have Education: Bachelor’s degree in Marketing, Communications, Business, Life Sciences, or a related field. Experience: >2 years of marketing experience, preferably in medical devices or healthcare; B2B experience a plus. Digital skills: Proficiency with marketing automation (e.g., HubSpot, Marketo), CRM (e.g., Salesforce), Google Analytics, SEO/SEM, and social media management. Language: Proficiency in English (written and spoken); additional languages a plus. Skills: Strong written and verbal communication; compelling content creation. Ability to analyze data, derive insights, and translate into action. Project management, budgeting, and vendor coordination abilities. Design sense for basic visuals or familiarity with design tools is a plus. Knowledge of regulatory considerations for medical devices in marketing materials is a plus. Nice-to-have Experience supporting product launches or lifecycle marketing in a regulated industry. Experience with events, webinars, and field marketing. Knowledge of ISO 13485-related processes or quality systems awareness. What we offer Competitive salary and benefits. Flexible work arrangements and a collaborative, innovative culture. Opportunities for professional growth and meaningful impact in the medical device field. How to apply Share your resume/CV and a brief cover letter outlining your marketing experience and why you’re interested in Sunmedic to [email protected]. If you’d like, include links to notable campaigns, case studies, or programs you’ve led. Öppen för alla Vi fokuserar på din kompetens, inte dina övriga förutsättningar. Vi är öppna för att anpassa rollen eller arbetsplatsen efter dina behov.