Quality & Regulatory Approval Specialist (f/m/x) with German
vor 22 Stunden
Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
This position is responsible for overseeing the Quality and Regulatory activities of the German, Austrian, and Swiss (DACH) commercial offices and warehouses, across to the several franchises of Smith+Nephew. The Quality & Regulatory Approval Specialist is also working closely with the Quality Team of our manufacturing site in Aarau, the Smith & Nephew Orthopaedics AG.
This position is located in Zug, Switzerland.
What will you be doing?
Maintain and manage the Quality Management System for DACH warehouses and commercial offices, ensuring compliance and efficiency
Develop, review, and improve quality processes and procedures to enhance clarity and regulatory adherence
Represent the company in audits and inspections by Certification Bodies, Notified Bodies, and Regulatory Authorities
Coordinate product holds, recalls, and complaint-related logistics, ensuring proper quarantine and compliance
Administer and support CAPA and Non-Conformance processes, including tracking, reporting, and facilitating corrective actions
Manage regulatory reporting and interactions with Competent Authorities for FSCA, vigilance, and post-market surveillance in DACH
Oversee regulatory registrations and re-registrations, collaborating with internal and external stakeholders
Support supplier management through audits, documentation control, and compliance oversight
What will you need to be successful?
University degree (Bachelor or Master) in e.g. Engineering, Medical Technology or a STEM subject or professional training with extensive relevant experience
Min. 3 years experience in Medical Device Quality Assurance or Regulatory Affairs (or in another regulated industry)
Solid knowledge of Medical Device Regulation (European Union Medical Device Regulation (EU) 2017/745 and other applicable laws and regulations in EU and Switzerland for medical devices
Knowledge of ISO 13485:2016, ISO 9001:2015
Understanding of Good Distribution Practices
Very good German and English language knowledge (written and spoken)
Travel Requirements: up to 20% within Switzerland, Germany and Austria
Beneficial:
Accredited Quality certificate (e.g. SAQ Quality Manager), or equivalent
Experience working in a global company with international teams
You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
Inclusion, Diversity and Equity: We are committed to Welcoming, Celebrating and Thriving on Diversity. Learn more about our on our website.
Benefits: Generous Annual Bonus and Pension Schemes, Save As You Earn share options.
Work/Life Balance: 25 Vacation Days per year as well as one extra day off each year for volunteering activities, so we can give back to our communities
Your Wellbeing: Employee Assistance Program (Mental Health), Life/Accident Insurance and much more
Flexibility: Adaptible working hours and possibility to work from home
Extra Perks: On-site parking, a modern office and free fruit, water & coffee
Please apply with your CV (PDF, English) and feel free to not include personal information like e.g. age, photo, nationality or family status.
Smith+Nephew is an equal opportunity employer. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
Smith & Nephew GmbH, Merve Krabbenhöft (she/her), Talent Acquisition Specialist, Theilerstrasse 1A, 6300 Zug
-
Senior Manager Quality Assurance
vor 1 Tag
Zug, Zug, Schweiz vVARDIS VollzeitSenior Manager Quality Assurance & Regulatory AffairsvVARDIS is a Swiss-based oral health company founded by Dr. Haleh and Dr. Golnar Abivardi, dentists, innovators, and award-winning entrepreneurs. vVARDIS is the result of a combined 30 years of dental and entrepreneurial experience, and 20 years of laboratory and clinical research paired with the creative...
-
Regulatory Affairs Manager
vor 21 Stunden
Zug, Zug, Schweiz EMEA Recruitment VollzeitRegulatory Affairs Manager (German Speaking) EMEA Recruitment is working with a well-established pharmaceutical business in its search for a German-speaking Regulatory Affairs Manager. Our client takes pride in quality in their portfolio, while improving the health of individuals globally. Based in Zug, the role offers hybrid working with a 50/50 model. The...
-
Senior Regulatory Affairs Specialist
vor 24 Stunden
Zug, Zug, Schweiz vVARDIS VollzeitAbout the RoleWe are seeking a skilled Quality Assurance & Regulatory Affairs professional to support our quality and regulatory compliance efforts for a broad portfolio of medical devices, pharmaceuticals, and cosmetics.This permanent position involves many points of contact internally and externally, so it is essential that you can build collaborative...
-
Regulatory Expert Lead
vor 24 Stunden
Zug, Zug, Schweiz vVARDIS VollzeitResponsibilities and SkillsThis is a comprehensive role that requires a strong analytical and problem-solving approach, as well as excellent communication skills.Key responsibilities include:Maintaining and enhancing our Quality Management System (QMS) in accordance with relevant regulations.Ensuring compliance across our portfolio of medical devices,...
-
Senior Director, Regulatory Strategy, Eu
vor 22 Stunden
Zug, Zug, Schweiz Tbwa ChiatDay Inc VollzeitSenior Director, Regulatory Strategy, EU About BridgeBio BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and...
-
Senior Director, Regulatory Strategy, EU
Vor 4 Tagen
Zug, Zug, Schweiz Tbwa ChiatDay Inc VollzeitSenior Director, Regulatory Strategy, EUAbout BridgeBioBridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the...
-
Quality Control Specialist
Vor 6 Tagen
Zug, Zug, Schweiz STAEGER PERSONAL PARTNERS VollzeitOur company is seeking an experienced Quality Control Specialist to strengthen our quality assurance team. As a key member of our team, you will play a crucial role in ensuring the quality and quantity of our metals trading operations.Job Description:Job Purpose:We are looking for a skilled professional to administer and control the quantity and quality of...
-
Senior Manager, Regulatory Affairs CMC
vor 21 Stunden
Zug, Zug, Schweiz Gilead Sciences Switzerland Sarl VollzeitDescription The CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs International Affiliate Team is seeking a motivated, curious, flexible, and culturally aware experienced Regulatory professional to assume a full-time employment position in Gilead's office in Zug, Switzerland in the capacity of CMC Regulatory Affairs Senior Manager ,...
-
Part Time
Vor 5 Tagen
Zug, Zug, Schweiz Atrinum. Group AG TeilzeitPart Time / Freelance Compliance OfficerATRINUM is a corporate and finance group. We encourage a very independent, flexible way of working. Become part of our growing team based in modern offices in the Park Tower in Zug.As Compliance Officer / AML Officer (m/f/x), you will support our operational team in all compliance and regulatory questions and...
-
Compliance Specialist
Vor 3 Tagen
Zug, Zug, Schweiz Monetum VollzeitAt Monetum, a Swiss-based fintech ecosystem, we are committed to bridging the gap between traditional finance and the digital economy. Fully compliant in Switzerland and the EU, our platform provides businesses and individuals with a secure environment for managing fiat and crypto transactions. Our services include named IBANs, instant euro and crypto...
-
Senior EU Regulatory Affairs Manager
Vor 4 Tagen
Zug, Zug, Schweiz Tbwa ChiatDay Inc VollzeitKey Responsibilities:Act as the EU strategic partner for regulatory teams at BridgeBio affiliatesServe as the primary liaison between BridgeBio Affiliates and EMAProvide strategic regulatory direction for the registration and development of new products in the EUDevelop and execute EU-specific regulatory strategies, including management of orphan product...
-
Supply Planning Manager, Amp-E
Vor 6 Tagen
Zug, Zug, Schweiz Ardagh Metal Packaging Europe GmbH VollzeitPosition Overview:The ideal candidate will be adept at driving constructive discussions with manufacturing teams, managing stakeholders in the mid-term planning process, and proactively ensuring collaboration between short-term and mid-term planning for flawless execution. This role demands a strategic thinker who has solid technical background from...
-
Supply Planning Manager, AMP-E
Vor 4 Tagen
Zug, Zug, Schweiz Ardagh Metal Packaging Europe GmbH VollzeitPosition Overview:The ideal candidate will be adept at driving constructive discussions with manufacturing teams, managing stakeholders in the mid-term planning process, and proactively ensuring collaboration between short-term and mid-term planning for flawless execution. This role demands a strategic thinker who has solid technical background from...
-
Global Quality Network Manager
Vor 3 Tagen
Zug, Zug, Schweiz Fraser Dove International Vollzeit**Global Quality Network Manager:**Join a renowned pharmaceutical organisation as a Global Quality Network Manager and take charge of shaping the regional commercial quality function.In this pivotal role, you will lead the transformation and standardisation of the Commercial Quality network, leveraging your expertise to drive strategic growth and elevate...
-
Supply Planning Manager, AMP-E
Vor 6 Tagen
Zug, Zug, Schweiz ARDAGH GROUP VollzeitPosition Overview:We are seeking a highly skilled and experienced Supply Planning Manager to lead our dynamic team in successfully executing the monthly and weekly planning process, with a focus on short term mid-term plans and long-term horizons. The ideal candidate will be adept at driving constructive discussions with manufacturing teams, managing...
-
Supply Planning Manager, AMP-E
vor 1 Tag
Zug, Zug, Schweiz Ardagh Glass Ltd. VollzeitSelect how often (in days) to receive an alert:Position Overview:We are seeking a highly skilled and experienced Supply Planning Manager to lead our dynamic team in successfully executing the monthly and weekly planning process, with a focus on short term mid-term plans and long-term horizons. The ideal candidate will be adept at driving constructive...
-
Commercial Quality Director
Vor 3 Tagen
Zug, Zug, Schweiz Fraser Dove International Vollzeit**Job Overview:**Foster a culture of quality excellence and drive transformative change as a seasoned leader within a leading pharmaceutical organisation.This is an exceptional opportunity to spearhead the regional commercial quality function, ensuring compliance, fostering innovative solutions, and elevating quality standards across the region.Key...
-
Regional Head of Commercial Quality
Vor 4 Tagen
Zug, Zug, Schweiz Fraser Dove International VollzeitGet AI-powered advice on this job and more exclusive features.Direct message the job poster from Fraser Dove InternationalTeam Leader TechOps & Quality | Executive Search | Helping Pharmaceutical Companies Transform Through Executive Search & Our Talent Ecosystem…Regional Head of Commercial QualityAre you passionate about Quality as a business partner?Do...
-
Chief Quality Officer
Vor 5 Tagen
Zug, Zug, Schweiz Pod Talent VollzeitJob Description:The company is looking for a highly experienced Chief Quality Officer - Consumer Products to lead their quality function. This is a unique opportunity to shape the future of quality and compliance within a dynamic organization.Your Key Responsibilities:Develop and implement a quality strategy aligned with business objectives, ensuring...
-
Global Quality and Compliance Leader
Vor 5 Tagen
Zug, Zug, Schweiz Pod Talent VollzeitCareer Opportunity:The company is seeking a seasoned Global Quality and Compliance Leader to lead their quality transformation initiative. This is a chance to shape the future of quality and compliance within a dynamic organization.Your Key Responsibilities:Develop and implement a quality strategy aligned with business objectives, ensuring compliance with...