Join our Team
As our customer base and service portfolio continue to develop and grow, we welcome applications from experienced candidates looking to join our dynamic organisation.
If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the medical technology industry, then a role as a Congenius Consultant could be your next rewarding career step. Read on to find out more about our open vacancies.
Current opportunities
Consultant Regulatory Affairs – IVD Medical Devices (m/f/d, 50-100%)
Reporting into our Head of Regulatory, Corinne Larke
Responsibilities
- Design Control: provide active regulatory guidance to project teams during new product development processes of In Vitro Diagnostic (IVD) medical devices
- Create regulatory strategies for the introduction of IVDs into EU and US markets
- Provide guidance and review for DHF documents
- Author US FDA submissions (510(k), De Novo or PMA) for IVD devices
- Author CE Technical Documentation per Regulation 2017/746 (IVDR)
- Work with EU Notified Bodies and US FDA for submissions
- Change Management: create regulatory assessments and change notifications for device changes throughout the product life cycle
Your Skills and Experience
- At least 5 years’ experience in regulatory affairs in IVD devices including knowledge of design control process requirements, and requirements for technical documentation for IVD devices
- Education in engineering, natural science or other related field, at least Master of Science (MSc)
- Experience with EU MDR 2017/745 is a bonus
- Independent, self-organised and hands-on attitude
- Systematic & analytical thinking, process-oriented and risk-based
- Strong decision maker, takes the lead where appropriate and necessary
- Ability to gain the trust of various stakeholders at various levels
- Fluent in English, and preferably German
Benefits
- You will work in the Zurich area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
- You’ll benefit from flexible working hours and an exciting and versatile field of activity
- You’ll work in a company with a flat hierarchy, short decision-making processes
- You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
- You’ll benefit from modern and attractive working conditions and development opportunities
- An attractive salary and very good social benefits round off the offer
Apply for this role via our LinkedIn Jobs page
Business Development Manager
Reporting into our CEO, Jörg Dogwiler
Responsibilities
- Secure and further develop existing business areas and operational project pipeline in the daily business
- Research and identify new business opportunities and projects, including growth areas, trends, customers, and partnerships
- Generate specific business leads and establish contact to decision-makers of prospective customers and partners and build strategic alliances
- Hold presentations, make offers, and negotiate on conditions in coordination with the Management Team
- Further develop the Customer Relationship Management (CRM) including toolset
- Support the company in actively responding to changing economic conditions and markets including strategy development
- Closely liaise with the CEO and department heads to deeply understand the service offering and coordinate promotional activities
- Perform a regular competitor analysis in close collaboration with the Head of Marketing & PR
- Continuously monitor progress and report status to the Management Team, making specific business development proposals
- Attend conferences and industry events where appropriate
Your Skills and Experience
- BSc / MSc in Engineering or Natural Science is a plus
- Comparable position/ proven track record as Business Development Manager in the Medical Device industry having a broad and useful network in this industry
- Entrepreneurial mindset
- Assertiveness and a confident manner in negotiations with customers or partners
- Strong communication and negotiation skills
- Analytical thinking and good organisational skills
- Creativity to develop new business areas
- Sense for economic trends and influences
- A pro-active, independent, goal- and action-oriented way of working
- Fluent in English and German
Benefits
- You will work in the Zurich area for an ambitious, dynamic, small company in the medical technology sector with a very good working atmosphere
- You will benefit from flexible working hours within an exciting and versatile field of activity
- You will work in a company with a flat hierarchy, with short decision-making processes
- You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
- You will benefit from modern and attractive working conditions and development opportunities
- An attractive salary and very good social benefits round off the offer
Apply for this role via our LinkedIn Jobs page
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