Turning breath into insights
At Halitus, we’re passionate about building diagnostic technology that frees humanity from debilitating diseases. We aim to make diseases from COVID-19 to cancer detectable within less than a minute, conveniently and non-invasive. If you get excited about shaping a future of healthcare that is proactive, intuitive to use, sustainable, and cost-effective, we'd love for you to join us. We’re an award-winning, purpose-driven Berlin-based DeepTech Start-up led by engineers and a doctor, supported by Roche’s RoX and backed by renowned investors.
The role
We’re looking for a regulatory affairs manager who assures that our processes and products meet consumers’ highest quality expectations and regulatory requirements. Our primary market is the European Union, and soon also the USA. You will lead the implementation and continuous development of our Quality Management System (QMS), engage with the relevant authorities and regulatory bodies, and provide regulatory support for development programmes of existing and new products. As a vital member of the cross-functional product development teams you support, you will actively collaborate to enable efficient and compliant full lifecycle medical device product management to satisfy business, market, and regulatory requirements.
Core responsibilities
The position requires strong technical writing skills, problem-solving, attention to detail, and the ability to collaborate across departments. You will be responsible for researching and effectively applying regulatory requirements to Halitus GmbH products. In collaboration with an expert advisory firm, you are responsible for developing our QMS, standard operating procedures, project plans, and regulatory strategy. This position requires a strong understanding of regulatory principles and strong organisational skills.
The key highlights of the role responsibilities and requirements are as follows:
Develops EU/Global regulatory strategies for new medical devices
Performs all duties and responsibilities as required by the Quality Management System Policies and Procedures
Provides leadership to the cross-functional team during new product development
Reviews protocols and reports to support regulatory compliance and submissions
Compilation of technical documentation for CE Marking, including Technical Files/Design Dossiers and Clinical Evaluation Reports
Maintains cooperative communications/collaboration with fellow employees, customers, contractors, and vendors
Critical review of project-specific documentation for compliance with the requirements of the applicable regulatory agency
Support initiatives in support of Quality Management System and other regulatory requirements
Participates or leads communication with notified body, and other regulatory inspections
Project management and task management
Performs other related duties and responsibilities as assigned
Requirements, education, and skills
Minimum:
Bachelor’s degree in a life science or technical discipline required; advanced degree preferred
Extensive experience with EU medical device regulations and submissions (MDD/MDR class II devices preferred)
Experience in ISO 13485 and CE marking incl. the preparation, management, and follow-up of external audits
Proficient knowledge of global regulatory submission requirements for medical devices
General understanding of product development process and design control
Excellent communication and interpersonal skills are essential
Ability to work in a fast-paced environment
Must be able to multi-task and meets deadlines as directed
Strong organizational, planning, and follow-up abilities
Outstanding command of English is a must
Conversational German skills with relevant domain knowledge are needed, too
Preferred:
Experience interfacing with FDA, Notified Bodies, and contract manufacturers
Experience supporting the regulatory aspects of clinical studies
Effective research and analytical skills
Effective written and oral communication, technical writing and editing skills
Specific experience with ML-based medical devices
Diversity & Inclusion
Halitus GmbH is committed to promoting a culture of diversity, equity, and inclusion and is proud to be an Equal Employment Opportunity and Affirmative Action employer. We believe that everyone in our tribe shares the responsibility of upholding our commitment to these values and encourage candidates from a wide range of backgrounds, perspectives, and lived experiences to join us in freeing fellow humans from some of the most feared diseases.
Halitus does not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Halitus is committed to working with and providing reasonable accommodations to applicants with physical and mental disabilities.
Halitus is committed to making the job application process accessible to everyone. If you are living with a disability (visible or not) and need to request a reasonable accommodation for any part of the application or hiring process, please let us know how we can help.
Contact us!
If you think we're a great mutual fit then we look forward to hearing from you — please send us your CV and a quick explanation of why this is a match made in heaven to . Thanks!