\\nJob 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\\xe2\\x80\\x99 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\\n \\n \\n \\n \\n \\n

\\n\\n Straumann Group\\n \\n\\n

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