Material Compliance Temporary Employee

vor 2 Wochen


Basel, Schweiz Straumann Vollzeit

As a Material Compliance Specialist specializing in CMR/ED substances, you will play a crucial role in ensuring that our medical devices meet the regulatory requirements set forth by the MDR GSPR 10.4. You will be responsible for collection information relation to CMR/ED substances from our suppliers and to analyze the documents for information related to chemical characterization. Liaise with suppliers to receive detailed information about the chemical characterization of supplied materials. Identify possible CMR/ED substances (Cancerogenic, Mutagenic, Toxic to reproduction/Endocrine disruptors) per harmonized listing and other applicable sources. You will be providing guidance to cross-functional teams, and ensuring that our materials are in full compliance with regulatory standards.

**Main Tasks and Responsibilities**:

- Substance Assessment and Monitoring:

- Conduct thorough assessments of materials used in medical devices to identify CMR/ED substances.
- Familiarize yourself with the CLP regulation and the ECHA website to identify CMR/ED substances.
- Monitor regulatory updates and changes related to CMR/ED substances.
- Supplier survey:

- Ensure compliance with MDR GSPR 10.4 by surveying our suppliers in a systematic, well-structured manner.
- Coordinate and keep track of the survey, collect feedback and proactively follow-up in case of missing or late response.
- Organize meetings with suppliers, Regulatory Affairs and Supplier compliance when required.
- Review the documentation from our supplier and maintain accurate records of CMR/ED substance assessments.
- Collaborate with Regulatory Affairs and Supplier compliance to document the supplier data in a consistent and good documentation practice.
- Documentation and Reporting:

- Prepare reports and documentation for demonstrating compliance to MDR GSPR 10.4

**Skills and Qualifications**:

- Bachelor's degree in a relevant scientific or engineering field (e.g., Chemistry, Materials Science, Chemical Engineering).
- Understanding of CMR and ED substances, as well as their regulatory implications.
- Familiarity with the Medical Device Regulation (MDR) and GSPR 10.4.
- Strong analytical and problem-solving skills.
- Excellent communication and teamwork abilities.
- Detail-oriented and capable of managing multiple tasks and priorities.


  • Material Scientist

    Vor 6 Tagen


    Basel, Schweiz Huntsman Vollzeit

    Job Description: Material Scientist (M/F) Role Overview: We are looking for an individual who is dedicated to laboratory research while simultaneously demonstrating a proactive and entrepreneurial approach. Role Responsibilities: As a Material Scientist, you will be responsible for: - Design and develop new materials based on process-structure-property...


  • Basel, Schweiz Work Selection Vollzeit

    **Beschreibung**: For our international partner based in Basel, we are looking for a qualified and motivated **Documentation and Compliance Manager** for a temporary contract of 12 months with a possible extension. Within the department, the chapter Product Care/Documentation and Compliance is accountable for Technical Support of marketed Combination...


  • Basel, Schweiz Bank J. Safra Sarasin Vollzeit

    Job Summary **Business unit** **Business Development** **Location** **Basel, CH** **Activity rate** **50-100%** **Publication date** **07.02.2023** **Reference** **2037** - About usAs a leading sustainable private bank, we offer dynamic and personalized services in investment advisory and asset management for private and institutional clients. Our...

  • Team Assistant

    vor 1 Tag


    Basel, Schweiz Synendos Therapeutics AG Vollzeit

    **Position Summary**: The Team Assistant is responsible for key administrative activities in the Company and supports the team with a number of control tasks. He/she will be a major contributor to the smooth running of the Company’s activities and will be able to plan and prepare for current and future administrative requirements. The role will require...

  • HR Generalist

    Vor 7 Tagen


    Basel, Schweiz Hawker Pacific Vollzeit

    Summary: Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel, Switzerland, to some 4,000 employees, and some 50 locations worldwide. Aircraft Management, Aircraft Sales, Charter, Completions, Defence, FBO, Fixed and Rotary Wing Maintenance, and Staffing. Behind every seamless Jet Aviation experience, is a team of...

  • Data Protection

    Vor 6 Tagen


    Basel, Schweiz UMS Skeldar Vollzeit

    Are you looking to join a fast paced, dynamic and innovation - driven company that operates on an international level with a hands-on attitude and entrepreneurial spirit? Do you describe yourself as a self-motivated person who wants to take on an active role in a small team and enjoys both, working independently and with internal and external customers? UMS...


  • Basel, Schweiz Global Personal Partner Vollzeit

    **EINFÜHRUNG**: Our profession and our passion "HR Management." Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of human resources services at 21 locations in German-speaking Switzerland. For our client, an international orientated Pharma company in Basel we are looking for a reliable...

  • EMEA Security Compliance Specialist

    Gefunden in: Talent CH C2 - vor 1 Woche


    Basel, Schweiz Adobe Vollzeit

    Our Company Changing the world through digital experiences is what Adobe’s all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences! We’re passionate about empowering people to create beautiful and powerful images, videos, and apps, and transform how companies...


  • Basel, Schweiz ITech Consult Vollzeit

    **Documentation and Compliance Manager** (f/m/d) - **Pharmaceutical **/** documentation **/** **project management / **GMP **/ **agile** **Project**: For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Documentation and Compliance Manager. Background: Within the department, the chapter Product Care/Documentation and...


  • Basel, Schweiz Arxada Vollzeit

    Arxada is a pioneering leader with a powerful legacy: Over 120 years of creating specialty chemicals and solutions that potentiate the performance of our customers and their products. Our solutions, our expertise and our support help them to perform better - to be more efficient, more effective and more sustainable. We are passionate about empowering high...


  • Basel, Schweiz Moderna Vollzeit

    **The Role**: The Sr. Director of Regulatory Process and Compliance position will work cross-functionally to drive activities that will ensure a state of continuous compliance at Moderna and build inspection-preparedness capabilities and sustain a positive compliance reputation between Moderna’s business partners, Health Authorities and cross-functionally...


  • Basel, Schweiz Lonza Vollzeit

    Switzerland, Basel - Switzerland, SteinToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their...


  • Basel, Schweiz MCH Vollzeit

    Coordinator of Unlimited Mediators 100% - Temporary from March 01 - June 30, 2023 Job ID 592 **Your responsibilities** - Support proofreadings - Participate at weekly Unlimited Jour Fixe meetings - Create special list with all relevant information about the artworks for the Guards on site - Prepare all relevant information for the meetings and instructions...


  • Basel, Schweiz Jet Aviation Vollzeit

    This position is responsible for the procurement of parts, material, and services in accordance with the applicable Aviation Regulations and company procedures as well as the order processing (price control of material and delivery date of material should correspond to customer request), reminder process for open orders, off core tracking. **Main...


  • Basel, Schweiz Sobi Vollzeit

    **Company Description** Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. Are...

  • GMP Compliance Specialist 80-100%

    Gefunden in: beBee S CH - Vor 7 Tagen


    Basel, Schweiz Work Selection Vollzeit

    #slim #content {border: none;margin: 0;padding: 0;} #slim .slim_picture {text-align: left;margin: 0 10px 20px 0;} #slim .slim_picture img {max-height: 126px;} #slim .slim_content {border: none;} #slim .slim_title {font-size: 24px;font-weight: bold;margin: 0 0 10px 0;text-align: left;line-height: 32px;word-wrap: break-word;} #slim .slim_text {padding: 0...

  • QA Manager

    vor 1 Tag


    Basel, Schweiz Personal Contact Basel AG Vollzeit

    Personal Contact vermittelt und verleiht seit über 25 Jahren erfolgreich qualifiziertes Personal in den Bereichen Industrie, Pharma, Technik und Gewerbe. Mit Fachkompetenz, Menschlichkeit und Engagement bietet Personal Contact lückenlose Dienstleistungen an, welche den höchsten qualitativen Ansprüchen des Personalwesens entsprechen. Für unseren...

  • QA Expert Compliance

    Vor 3 Tagen


    Basel, Schweiz Lonza Vollzeit

    Switzerland, BaselToday, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big...

  • QA Expert Compliance

    Gefunden in: Talent CH C2 - vor 1 Woche


    Basel, Schweiz Lonza Vollzeit

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...


  • Basel, Schweiz Huntsman Vollzeit

    Job Description: Role Overview: As part of the Advanced Materials division, Huntsman is looking for an Organic Synthesis Chemist who will join our Global Innovation Team. The position is a full-time contract based in our Advanced Materials European HQ in Basel, Switzerland. Role Responsibilities: As an Organic Synthesis Chemist you will: - Identify,...