Regulatory Affairs Specialist - Biological Evaluation (f/m/d)
Responsibilities :
- Interpret ISO 10993 requirements and evaluate outcomes considering device factors, intended use, and scientific knowledge
- Create biological evaluation plans / reports and coordinate biological testing with external labs and Toxicologists
- Support the development of biological strategy
- Assistance to representatives of the Business Division and HARTMANN in working groups related to changes in legislation or standards
- Establish and maintain contacts with testing institutes and external service providers
- Collaborate with departments like R&D, Manufacturing Engineering and Procurement to ensure biological evaluations comply with EN ISO 10993
- Assess biocompatibility of materials, support product registration, and contribute to risk analysis and clinical evaluation reviews
Qualifications :
- Degree in natural science, life science or engineering
- Knowledge in scientifc and / or clinical working (e.g. chemical, microbiological or quality lab)
- Knowledge in the field of medical devices, regulatory affairs or quality management desired
- Willingness to learn about new technologies and materials
- Analytical, organizational and communication skills
- Fluency in German and English
Benefits :
- Flexible working conditions, such as flexible working hours and mobile working
- Attractive ways of combining work and family life, e.g. childcare subsidy
- 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement
- Company pension plan with attractive employer contribution incl. matching model for deferred compensation
- Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop
- Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass)
- Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc.
- Job Bike Leasing
- Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform
Regulatory Affairs Manager for Clinical Evaluation (f/m/d)
As a Manager Regulatory Affairs Clinical (f/m/d), we offer you a varied and challenging position in an international environment. Provide and update documentation of clinical evaluation, post-market clinical follow-up and post-marketing surveillance. Coordinate external service providers to support ...
Regulatory Affairs Specialist
Minimum of years plus experience in Regulatory Affairs. Manages and coordinates international product registration submissions, oversees status of internal regional regulatory activities; ensures compliance with relevant regulations and standards. Leads Regulatory on Global product registrations in ...
Quality & Regulatory Affairs Specialist - Capital Equipment (m/w/d) - Now Hiring!
As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance. ...
Regulatory Affairs Specialist Germany (m/w/d)
Ouml;rtlicher Regulatory Kontakt:. Europäisches Regulatory Team:. Kulinaria Deutschland) und diesbezüglich enge Zusammenarbeit mit dem deutschen Geschäftsführer und dem Corporate Regulatory Manager. ...
Quality & Regulatory Affairs Specialist - Capital Equipment (m/w/d)
As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance. ...
Quality & Regulatory Affairs Specialist - Capital Equipment (m/w/d) - Urgently Hiring!
As a Quality & Regulatory Affairs Specialist (m/w/d), you will be in charge of providing support to Capital Equipment servicing as well as to EMEA Quality and Regulatory Organisation to ensure quality and regulatory compliance. ...
Product Manager (m/w/d) - Payment/Banking
Product Manager (m/w/d) - Payment/Banking. ...
Senior Business Analyst E-Commerce (m/w/d)
Senior Business Analyst E-Commerce (m/w/d)WAS UNS ÜBERZEUGTErfolgreich abgeschlossenes technisches oder wirtschaftliches Studium. Mehrjährige Erfahrung als Business Analyst, idealerweise im E-Commerce. ...
Production Quality Manager*in (w/m/d)
Für den Bereich "Production Quality" suchen wir am Standort in Oberkochen zum nächstmöglichen Zeitpunkt eine*n Production Quality Manager*in (w/m/d) Die Abteilung "Production Quality" ist verantwortlich für die Sicherstellung der effizienten Problemlösung in der Wertschöpfungskette und die p...
Risk Manager, Regulatory Intelligence, Safety and Compliance (RISC)
Here at Selling Partner Services, we embrace our differences.We are committed to furthering our culture of inclusion.We have 14 employee-led affinity groups, reaching 10,000+ employees in chapters globally.We have innovative benefit offerings, and we host annual and ongoin....