Overview: As a Regulatory Compliance Specialist, you will ensure that wearable IoMT devices meet the rigorous standards set by both the EU Medical Device Regulation (MDR) and Medical Device Directive (MDD). This role involves mastering the regulatory requirements, preparing compliance documentation, and maintaining oversight throughout the product lifecycle. Working remotely on a part-time basis, you will guide the development teams through the complex regulatory landscape.
Responsibilities:
- Develop and implement regulatory strategies that comply with both MDR and MDD standards for wearable IoMT products.
- Prepare and manage documentation for compliance, including Technical Documentation and Declarations of Conformity under MDR and MDD frameworks.
- Stay updated on changes in the regulatory environment in the EU, interpreting how legislative developments affect wearable medical devices.
- Conduct internal audits and coordinate with external regulatory bodies to ensure ongoing compliance.
- Assist product development and quality assurance teams to integrate MDR and MDD requirements into product designs and production processes.
Required Skills:
- Expert knowledge of EU regulations concerning medical devices, particularly the MDR and MDD.
- Ability to navigate complex regulatory documents and translate requirements into actionable compliance strategies.
- Proficient in regulatory submission tools and document management systems.
- Strong organizational skills, attention to detail, and the ability to manage multiple projects simultaneously.
- Excellent communication skills, capable of liaising with international regulatory agencies and internal teams.
Qualifications:
- Bachelor’s or Master’s degree in Regulatory Affairs, Biomedical Engineering, or a related field.
- At least 4 years of experience in regulatory affairs, with a strong focus on medical devices regulated under MDR and MDD.
- Professional certification in regulatory affairs, such as RAC, is preferred.
Work Mode:
- This position offers remote, part-time work, allowing for flexible hours to manage tasks and collaborate with teams across various time zones.
- Requires participation in regular update sessions and compliance trainings to stay current with regulatory changes and best practices.
Responsibilities:
- Develop and implement regulatory strategies for new and existing wearable IoMT products.
- Prepare and submit documentation required for regulatory approvals, including FDA, CE marking, and other international health regulatory bodies.
- Stay current with changes in regulatory requirements and guidance documents, and inform relevant teams of applicable updates.
- Conduct internal audits to ensure ongoing compliance with all regulatory requirements.
- Work closely with product development and quality assurance teams to ensure regulatory considerations are integrated into product design and manufacturing processes.
Required Skills:
- In-depth knowledge of regulatory requirements for medical devices, particularly wearable technologies, including FDA and CE marking standards.
- Ability to manage complex projects and timelines within a regulatory framework.
- Strong organizational skills and attention to detail.
- Excellent written and verbal communication skills, necessary for preparing detailed regulatory documents and interacting with regulatory bodies.
- Proficiency with regulatory submission software and document management systems.
Qualifications:
- Bachelor’s or Master’s degree in Regulatory Affairs, Biomedical Engineering, or a related field.
- At least 3 years of experience in regulatory affairs, specifically in the medical device sector.
- Professional certification in regulatory affairs (RAC) preferred.
Work Mode:
- This is a remote and part-time position, which requires flexibility to interact with international regulatory bodies across different time zones.
- The role may involve periodic updates and training sessions to stay aligned with global regulatory changes and best practices.
Our Business Model and Values
Arbitrage Investment AG is an investment and holding company focused on innovative and long-term growth markets. Our portfolio spans a variety of sectors including fintech services, renewable energies, biotechnology, medical technology, and advanced artificial intelligence. We aim to consistently grow and innovate through risk-averse arbitrage strategies and diversified investment management.
Our subsidiaries are industry leaders, characterized by their economic efficiency and forward-thinking nature. Sustainable development and the long-term success of these companies are at the heart of our actions. We play an active role in managing, supporting, and advancing our investments to enhance their growth and, when necessary, support their expansion and internationalization.
In collaboration with the management and employees of our subsidiaries, we position ourselves as strategic partners and catalysts. We leverage our extensive experience and expertise to promote synergies and facilitate idea sharing and cooperation among our companies in areas such as research and development, HR management, and talent development.
Despite our close collaboration, it is important to us to maintain the autonomy of our subsidiaries. Their success is based on the competence and dedication of outstanding professionals. With our experienced consultancy, we stand by their side to help achieve common goals and explore new market opportunities.
This is what defines us: Arbitrage Investment AG – Innovative, sustainable, and forward-looking, committed to developing markets and technologies that will shape the world of tomorrow.
Kontakt
| Tarik Bolat |
| Team Leader Recruiting |
| Max-Planck-Str. 22, 50858 Köln |
| www.arbitrageinvestment.de tb@arbitrageinvestment.de |
| Telefon: +49 221 292473-10 Fax: +49 221 292473-11 |
| Börsenplatz: Hamburg, ISIN DE000A3E5A26 / WKN A3E5A2 |
| Registergericht: Amtsgericht Köln Registernummer: HRB 112260 Steuernummer: 64/211/04758 Umsatzsteuer: DE285620756 |
