Ra&c Manager

Vor 2 Tagen

Basel, Schweiz Straumann Group Vollzeit

**Job Purpose**
As Regulatory & Compliance Manager Biomaterials, you will be part of a small but highly motivated and very international team dedicated to our Biomaterials product portfolio. With your regulatory and compliance knowledge, you will support product developments and life cycle activities for the Biomaterial portfolio in order to expand the availability of the products worldwide.

**Main Tasks and Responsibilities**
- Ensure product development process is supported and the compliance of development deliverables, even in less routine situations, through problem solving.
- Support/Review/Approve labeling (Labels, IFU’s, relevant Marketing Material) to ensure regulatory compliance.
- Support/review/approve design verification & validation activities
- Create and maintain Design Dossiers for EU for both MDD 93/42/EEC & MDR EU 2017/745 and ensure compliance with other RA relevant matters of MDR EU 2017/745 (e.g. EUDAMED, UDI, local registration CE+, information to distributors)
- Compile and support regulatory submission files for various jurisdictions worldwide in compliance with relevant regulations
- Support during audits and inspections.
- Engage with the other departments in regard to understanding and implementating of regulations/laws/guidelines/state of the art ensuring that conflicts are resolved with strong influencing and problem solving skills.
- Monitoring and communication of new regulatory requirements and support in implementing these.

**Profile**
Education
- Technical or scientific graduate degree (FH/Uni/ETH)
- Fluent (written and spoken) in English, strong command in technical writing

Experience
- 3 to 5 years professional experience in Regulatory Affairs and/or Quality Management
- Detailed knowledge about the standards and norms for Medical Devices such as ISO 13485, ISO 14971, 93/42/EEC & EU 2017/745, FDA and Health Canada requirements.
- Experience with other jurisdictions (APAC, LATAM and DEMEA) would be beneficial
- Experience with Biomaterials and class lll products would be an asset

Personal Attributes & behaviors
- Positive and enthusiastic person with an accommodated and helpful approach
- Able to make favorable impressions and create a positive and innovative atmosphere
- Cultivate a network of productive relationships in an international matrix environment
- Proactive and flexible individual with string analytical skills, seeking to get things done and at the same time deal with a high variety of tasks

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**:9785

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