Post Market Surveillance Manager
vor 6 Monaten
**Job Purpose**
The Post Market Surveillance Manager within the Corporate Quality Management and Regulatory department is responsible for ensuring that the necessary processes associated with the PMS of released products is implemented in accordance with the relevant and applicable procedures In this role the PMS Manager, coordinates and trains the relevant positions within the PMS and product design teams. The PMS Manager also supports the Product Safety Officer (PSO) with regard to submission of reports to authorities in the cases of Adverse Events or Field Safety Corrective Actions.
**Main Tasks and Responsibilities**
- Responsibility to assure conformance of Post Market Surveillance processes at Straumann with the relevant legal and regulatory requirements
- Defining and implementing PMS Report/ PSURs schedule according to the PMS procedure
- Preparing the PMS Plans with the cross-functional PMS team for approval and release
- Creating the PMS Reports/PSURs with the cross-functional PMS team for approval and release
- Support the Design & Development teams by providing the necesssary PMS input in a timely manner
- Provide appropriate input to management processes e.g. CAPA, Management Review
- Understand and support input / output processes like Complaint Handling, Adverse Event and Field Safety Corrective Action Reporting and Risk Management
**Profile**
- Training in Quality Management and Quality systems with knowledge and understanding of the PMS requirements including necessary authority reporting such as ISO 13485, EU MDR 93/42 EEC, QSR
- Strong analytical skills (statistical analysis experience preferred)
- Fluent in English. Knowledge in German is advantageous but not a must.
Education
- Technical professional education or natural scientific graduate degree (FH/Uni/ETH)
Experience
- Minimum of 2 years’ experience in Quality Management or regulatory affairs in Medical Device Industry
Active functional experience in one or more of the following areas:
- Post Market Surveillance
- Change Management
- Document Control
- CAPA management
- Complaints management
- Risk management
- Adverse Event Reporting, including Field Safety Corrective Actions
Personal Attributes
- Ability to work in cross-functional teams
- Distinctive interpersonal skills with customer focus
- Communicative and professional with an independent and team-oriented work behavior
- Actively cultivates a network of productive relationships in an international environment
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or disability.
**Employment Type**:Full Time
**Alternative Locations**:Switzerland : Basel
**Travel Percentage**:0 - 10%
**Requisition ID**:11299
-
Trainee Post Market Surveillance
vor 7 Monaten
Basel, Schweiz Straumann VollzeitThis internship is a great opportunity to get exposure and first hands on experience in some of the most audited topics of medical device quality management (in accordance with ISO 13485; 21 cfr 820; Regulation (EU) 2017/745 (EU MDR); ISO 14971). You will take part in a three-step rotation program where you spend time in the following sub-departments: Post...
-
Industry Market Manager Synthesis
vor 7 Monaten
Basel, Schweiz Brenntag Vollzeit**INDUSTRY MARKET MANAGER SYNTHESIS & BIOPHARMA**: Our team in **Basel** currently has an opening for a **Industry Market Manager Synthesis & Biopharma** > **YOUR ROLE & RESPONSIBILITIES**: Our Brenntag Pharma EMEA division builds the link between Raw Material suppliers and Medicinal Product Producers and manages the Distribution of APIs, Excipients,...
-
Basel, Schweiz Julius Baer VollzeitAt Julius Baer, we celebrate and value the individual qualities you bring, enabling you to be impactful, to be entrepreneurial, to be empowered, and to create value beyond wealth. Let’s shape the future of wealth management together. In the area “Clients, Compliance & Channels” we’re looking for an “IT Application Responsible” (AR) to strenghten...
-
Market Intelligence Manager
vor 7 Monaten
Basel, Schweiz Lonza VollzeitSwitzerland, 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...
-
Market Insights Lead
vor 7 Monaten
Basel, Schweiz Sobi Vollzeit**Role and Functions** - Proactively seek information on the external environment and emerging competitive landscape - From multiple internal/external sources including customer networking, congresses & commissioned work - Primary focus is to drive the development of the global understanding of the competitive landscape and market environment for Sobi’s...
-
Sales Manager
vor 6 Monaten
Basel, Schweiz Nexoya Vollzeit**Work setting: Hybrid ** **Workation: 1 x year** **Location: Milano, Zürich or Berlin** **OUR COMMON **VISION** Empowering marketers to make data-driven decisions with transparency, independence and the power of artificial intelligence (AI). **YOUR MISSION** Your mission as a Sales Manager is to drive our AI-powered solutions into the hands of...
-
Director of Market Access Strategy
vor 3 Wochen
Basel, Basel-Stadt, Schweiz IQVIA VollzeitJob Summary">This is a unique opportunity to lead the pricing and market access offerings in Switzerland, working closely with IQVIA's clients in the pharmaceutical, biotechnology, and medical devices sectors. The ideal candidate will have a strong understanding of drug price strategy and negotiations, as well as experience navigating HTA processes...
-
Global Customer
vor 2 Monaten
Basel, Schweiz Jet aviation VollzeitSince 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...
-
Global Customer
vor 2 Monaten
Basel, Schweiz General Dynamics Corporation VollzeitResponsibilities for this PositionLocation: Basel, CHFlexible Work Arrangement: HybridCareer Level: ProfessionalRequisition Id: 3193Position SummaryFuel strategic growth and insight at Jet Aviation! As our Senior Manager, Global Customer and Market Intelligence, based either in Zurich or Basel, you will leverage advanced analytics to drive strategic...
-
Global Market Insights Associate
vor 7 Monaten
Basel, Schweiz Work Selection Vollzeit**Beschreibung**: We are looking for a motivated and dedicated **Global Market Insights Associate** for our client, F. Hoffmann-La Roche Ltd. based in Basel, for a temporary assignment of 6 months with option to extend. Roche is strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds,...
-
Eu & New Markets ERP Fi/co Solution Manager
vor 7 Monaten
Basel, Schweiz BeiGene VollzeitGeneral Description: GlobalTechnology Solutions serves the BeiGene organization with infrastructure, systems, and services that provide the foundational, maturity, governance, and innovation needed to serve patients around world. BeiGene takes the approach that access to life-changing medicine sees no borders, and GTS affects this perspective by delivering a...
-
Junior Portfolio Manager Private Markets
Vor 2 Tagen
Basel, Schweiz F. Hoffmann-La Roche Gruppe VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Junior Portfolio Manager Private Markets
Vor 2 Tagen
Basel, Schweiz Roche VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Director, Market Access Ceeg
vor 7 Monaten
Basel, Schweiz BeiGene VollzeitNO AGENCIES General Responsibilities: Reporting into the Senior Director, Market Access Sub-Region Europe (SRE), the Director Market Access CEEG is responsible for the Market Access and Pricing of BeiGene’s assets in the CEEG cluster of SRE. The geographic scope of CEEG (Central and Eastern Europe, Greece, Cyprus and Malta) and therefore this role...
-
Global Customer
vor 2 Monaten
Basel, Schweiz Jet Aviation AG VollzeitGlobal Customer & Market Intelligence Analyst Location: Basel, CH Flexible Work Arrangement: Hybrid Job Category: Customer Standards & Services Career Level: Professional Requisition Id: 3193 Since 1967, Jet Aviation has been crafting flight in its smoothest form. From one hangar in Basel,...
-
Orthodontics Growth Manager
vor 7 Monaten
Basel, Schweiz ClearCorrect Vollzeit**Summary**: **Responsibilities**: - Work closely with the Hub Head to develop and execute comprehensive sales strategies that drive revenue growth and achieve sales targets within the Hub. - Oversee the end-to-end launch management ensuring successful commercialization. - Co-define product positioning, pricing strategies, and go-to-market plans to maximize...
-
Market Access Us Lead
Vor 5 Tagen
Basel, Schweiz ARTIDIS Vollzeit**Job Purpose** The Market Access US Lead, is responsible for building up core commercial capabilities and marketing strategies needed to ensure the commercial success of the US launch. The function will focus on the roll-out of early access programs in our launch centers and assist in the deployment of the market access strategy and tactics to support the...
-
Manager Workplace Services Europe, MENA
vor 1 Monat
Basel, Schweiz BeiGene, Ltd. VollzeitManager Workplace Services Europe, MENA & New MarketsApply locations Basel time type Full time posted on Posted 2 Days Ago job requisition id R26895BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly...
-
Global Market Insights Associate for F. Hoffmann La
vor 7 Monaten
Basel, Schweiz We make it GmbH VollzeitWe make it GmbH is a nationally active company in Switzerland which, thanks to many years of successful experience, has a high level of expertise in the field of personnel services. expertise in the field of personnel services. Its recruitment activities are focussed on the core areas of industry, technology, office/administration, engineering,...
-
Market Access
vor 2 Monaten
Basel, Schweiz Axmed VollzeitWe are seeking a detail-oriented and experienced Advisory Associate to support our clients on the development of strategic market access and pricing plans, as well as a robust framework for launch dossiers development for several groundbreaking pharmaceutical products in key emerging markets. This position will focus on building robust market access...