Junior Homologation Specialist
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Would you like to work with products that actually change the lives of people worldwide and do it in a fast-growing company Then we can offer you the right challenge! Right now we are looking for a dedicated and skilled Junior Homologation Specialist to support Demant. If you already have experience with homologation or any other well-regulated areas it would be great but not necessary.
Working with us gives you the opportunity not only to plan your own work and be largely self-managed but also to become a part of an experienced team of specialists capable of working in a dynamic and challenging international organization.
We are a small and dedicated team of people situated in Poland and Denmark and we are responsible for the regulatory strategy for each project and for project support throughout the product development process.
Among other tasks the team is managing classification activities risk management file processes device and facility registrations radio approvals electrical safety approvals plus standard and regulation requirements. Furthermore the team is involved in internal audit and system compliance according to EN ISO 13485 and FDA 21 CFR 820 and we are continuously involved in improvement projects.
Working with us you will receive:
full-time work agreement with a permanent contract after 3 months;
flexible working hours and hybrid workplace;
possibilities to improve English by daily usage (courses offered);
relocation package if needed;
great opportunities for usage of newest technology;
possibility of hybrid system work;
social benefits;
Scandinavian culture we are informal (we dont use titles: Sir Mr Mrs Miss) and care about Diversity Equity and Inclusion independence open dialog and work-life balance.
What task are waiting for you
Collect and submit relevant data for authorities.
Cooperation with external stakeholders in regard to registrations.
Working with regulations.
Collect documentation packages for registration purpose.
Monitor and communicate regulatory changes.
Maintain and update regulatory registration documents.
Communication with internal and external stakeholders.
Other administrative tasks.
It would be great if you:
have bachelors degree in: law administration medicine chemistry pharmacy or similar but your educational background is not decisive;
are fluent in English both written and spoken and you have good communication skills
have experience in working with documentation management;
have a sense for details without losing the overview;
are proactive and outgoing personality and a strong will to learn;
are a team player and like when things go fast;
already have been dealing with regulatory work in the medical devices business or any other well-regulated areas- it would be great but not necessary;
like working with computer systems base data etc.;
are a self-managed and organized person and have a structured and disciplined work approach;
are willing to travel to Denmark for training and coordination purposes when required.
If you have any questions contact the recruiter: Jakub ()
Furthermore we would like to inform you that the company has an internal reporting procedure which is available at:demantcompliance - Make a report ()
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Required Experience:
Junior IC
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
Leading in hearing healthcare Demant is the only company in the world that covers all areas of hearing healthcare, from hearing devices and hearing implants to diagnostic instruments and professional hearing care, and we harvest significant synergies from this unique position and exp ... View more
