Quality and Regulatory Expert
vor 3 Wochen
An esteemed pharmaceutical company based in Basel, Switzerland, is seeking a highly skilled Quality and Regulatory Associate to join their dynamic team. This exciting opportunity will allow the successful candidate to work closely with the International QARA Director in managing the company's global QA and RA functions.
With impressive year-on-year growth of 200%, this innovative company is expanding rapidly, boasting eight products on the market and five more in development. One of these upcoming products is set to launch early next year.
Key Responsibilities:
- Develop, implement, and maintain SOPs, Work Instructions, Non-Conformities, Change Control, CAPA, Artworks, and related documents.
- Maintain and update all documents within the company's system.
- Provide support for internal and external audits.
- Assist in regulatory document preparation (Technical File) and collaborate with the Regulatory Manager during the transition from MDD to MDR.
- Cover worldwide registration and compile regulatory submissions, including legalization activities.
- Liaise with local agents and distributors to facilitate their registration process.
- Ensure accurate maintenance of regulatory records and databases.
Requirements:
- At least three years of experience in a similar role.
- Strong knowledge of regulatory regulations and Quality Systems, including ISO13485, MDD, MDR, and MDSAP requirements in relation to QMS activities.
- Experience within the Medical Device or Pharmaceutical industry.
- A proactive self-starter able to work independently.
- Exceptional communication skills for effective stakeholder liaison.
- Fluent written and spoken English essential; Spanish an advantage.
Compensation:
The estimated salary for this position ranges between $60,000 and $90,000 annually, depending on qualifications and experience. The package may also include additional benefits such as bonuses, health insurance, and professional development opportunities.
-
Regulatory Affairs Expert
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Straumann Group VollzeitJob Summary:As a Regulatory Affairs Expert at Straumann Group, you will be responsible for ensuring that all products in scope are designed, manufactured, and distributed in compliance with applicable regulatory requirements.Main Responsibilities:Ensure product compliance with regulatory requirementsInteract with authorities and other approving bodiesGuide...
-
Digital Transformation Specialist
vor 1 Monat
Basel, Basel-Stadt, Schweiz We make it GmbH VollzeitWe Make It GmbH is a leading personnel services company in Switzerland, boasting extensive expertise in the industry. With a strong focus on quality, ethics, and discretion, we deliver exceptional recruitment services to our clients.About the RoleThis challenging position as Digital Transformation Specialist - Regulatory and Quality requires an experienced...
-
Global Regulatory Quality Assurance Associate
vor 1 Monat
Basel, Basel-Stadt, Schweiz Stratpharma AG VollzeitAn exciting opportunity has arisen for a highly motivated Quality Assurance and Regulatory Associate to join our ambitious forward-thinking team at Stratpharma AG in the centre of Basel. This role will work closely with our International QARA Director in managing the company's global QA and RA functions.As a highly successful company with an impressive 200%...
-
Comprehensive Quality Assurance Expert
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitJob Title: Comprehensive Quality Assurance ExpertAbout Gi Group SA:Gi Group SA is a dynamic and professional recruitment agency with a strong focus on the pharmaceutical industry. Our team of experts has extensive knowledge and experience in finding top talent for our clients.Job Description:We are currently looking for a Comprehensive Quality Assurance...
-
Director of Global Quality Systems and Excellence
vor 3 Wochen
Basel, Basel-Stadt, Schweiz BeiGene VollzeitAbout the RoleWe are seeking a highly experienced Director of Global Quality Systems and Excellence to join our team at BeiGene. This is an exciting opportunity for a motivated individual to play a pivotal role in ensuring the consistent implementation and alignment of global quality policies, procedures, and GxP standards across local and regional...
-
Product Safety Specialist
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Randstad VollzeitWe are seeking a highly skilled Product Safety Specialist to join our team in Basel, Switzerland. As a key member of our Compliance Operations department, you will be responsible for ensuring the data and processes within Diagnostics Quality & Regulatory enable a chemical and environmentally compliant and sustainable development, transport/handling,...
-
Quality Assurance Manager
vor 2 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitGi Group SA is seeking a Quality Assurance Manager to join their team in Basel. As a Senior Quality Expert, you will be responsible for reviewing and approving SOPs, protocols, reports, Certificate of Analysis, and other quality-related documents.About the RoleThis is a unique opportunity to work with a dynamic team in the pharmaceutical industry. The...
-
Director of Quality and Compliance Oversight
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Veristat VollzeitJob OverviewThe Associate Director, Quality Assurance and Compliance (QAC) role at Veristat Europe is a critical position that requires expertise in quality management, compliance, and regulatory affairs.About UsVeristat is a global expert in clinical development with over 27 years of experience supporting rare disease clinical trials. Our team has supported...
-
Scientific Regulatory Expert
vor 1 Monat
Basel, Basel-Stadt, Schweiz Exponent Vollzeit{"Our Opportunity":{"title":"Our Opportunity","content":"We are seeking a Managing Scientist for our Practice in various locations. Remote working is also an option. As part of a team, you will provide regulatory and technical expertise in Biocide Regulatory Affairs. You will assist in developing and implementing a regulatory strategy for new and existing...
-
Regulatory Strategy and Submissions Lead
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitAbout the RoleWe are seeking a highly skilled Regulatory Strategy and Submissions Lead to join our Pharma Development Regulatory (PDR) organization at Roche. This is an exciting opportunity to develop and maintain licensees that permit us to market and sell life-improving therapies worldwide.As a Clinical Trial Regulatory Lead, you will lead the clinical...
-
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitGi Group SAWe are seeking a highly skilled Senior Quality Assurance Expert to join our team in Basel, Switzerland. This is a full-time position offering an attractive salary package.The ideal candidate will have a Master's degree in analytical chemistry, biochemistry, or life sciences and at least 7 years of experience in the analytical-pharmaceutical...
-
Global GCP Inspection Lead
vor 4 Wochen
Basel, Basel-Stadt, Schweiz BeiGene VollzeitJob DescriptionThe Global GCP Inspection Lead plays a critical role in ensuring the quality and integrity of clinical trials conducted by BeiGene. This position requires an expert with a deep understanding of international regulatory requirements and standards, as well as excellent leadership and communication skills.About the JobThis position is responsible...
-
Regulatory Affairs Director
vor 1 Monat
Basel, Basel-Stadt, Schweiz Ironwood Pharmaceuticals VollzeitKey Responsibilities:As a crucial member of Ironwood Pharmaceuticals' Regulatory Affairs team, you will develop and implement global regulatory strategies for assigned projects and products, ensuring timely development and submission of regulatory materials. Your expertise will help navigate complex regulatory landscapes, drive strategic planning, and foster...
-
Regulatory Compliance Specialist
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitAbout Gi Group SAGi Group SA is a leading recruitment agency in the pharmaceutical industry, dedicated to providing top talent to our clients.Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled and experienced Regulatory Compliance Specialist to join our team in Basel. As a key member of our Quality Assurance department, you will be...
-
Material Declaration Specialist
vor 2 Wochen
Basel, Basel-Stadt, Schweiz ITech Consult AG Vollzeit**About the Role:**We are seeking a highly skilled Material Declaration Specialist - Regulatory Compliance Expert to join our team at ITech Consult AG. As a key member of our global unit, you will be responsible for ensuring compliance with chemical and environmental regulatory legislation across all our products and services.The ideal candidate will have...
-
Global Head of Quality Operations
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Lonza VollzeitQuality Operations LeadLonza is a global leader in life sciences operating across three continents. Our approach to quality is rooted in the belief that talented people working together can devise ideas that help businesses improve lives. To achieve this, we empower our teams to own their careers and drive innovation. We are seeking a Global Head of Quality...
-
Regulatory Affairs Specialist
vor 1 Monat
Basel, Basel-Stadt, Schweiz Exponent VollzeitOur OpportunityWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Exponent. This role will involve providing regulatory and technical expertise in Biocide Regulatory Affairs, working as part of a team to develop and implement regulatory strategies for the approval of new and existing active substances.You will be responsible...
-
Global Head of Quality Operations Executive Lead
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Lonza VollzeitJob DescriptionLonza is a global leader in life sciences operating across three continents. We are seeking a highly experienced professional to lead our Biologics Quality Operations as Global Head of Quality Operations, Biologics. This role is responsible for providing technical Quality/Regulatory-related expertise and Quality Operational Management...
-
Regulatory Efficacy Specialist
vor 1 Monat
Basel, Basel-Stadt, Schweiz Exponent VollzeitOur OpportunityWe are seeking an efficacy expert to work within our Practice in multiple international locations; homeworking may also be considered. In this role, you will work as part of a team to prepare regulatory dossiers with respect to efficacy for plant protection products.Key ResponsibilitiesProvide strategic advice and guidance to clients on EU and...
-
Regulatory Affairs Team Lead
vor 1 Monat
Basel, Basel-Stadt, Schweiz Straumann Group VollzeitJob Title: Regulatory Affairs Team LeadAbout the Role:We are seeking a highly skilled Regulatory Affairs Team Lead to join our team at Straumann Group. The successful candidate will be responsible for ensuring that all products in scope are designed, manufactured, and distributed in accordance with applicable regulatory requirements.Main Responsibilities:*...