Regulatory Affairs Specialist
at Interacoustics
5500 Middelfart, Region Syddanmark, Denmark -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 06 Oct, 2024 | Not Specified | 06 Jul, 2024 | 2 year(s) or above | Medical Devices | No | No |
Required Visa Status:
Citizen | GC |
US Citizen | Student Visa |
H1B | CPT |
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Employment Type:
Full Time | Part Time |
Permanent | Independent - 1099 |
Contract – W2 | C2H Independent |
C2H W2 | Contract – Corp 2 Corp |
Contract to Hire – Corp 2 Corp |
Description:
ABOUT US
Interacoustics has been a global leader in diagnostic hearing and balance solutions for over 50 years. Helping people overcoming their hearing and balance challenges has been part of our DNA from the beginning. Our values are the cornerstone of everything we do. We are committed to maintaining a culture of trust, flexibility, and personal growth, leveraging innovative technology to deliver innovative products and services. We thrive in a vibrant international environment that encourages open-mindedness and social engagement.
AT INTERACOUSTICS WE ARE COMMITTED TO CREATING AN INCLUSIVE WORKING ENVIRONMENT. WE WELCOME APPLICATIONS FROM ALL QUALIFIED CANDIDATES REGARDLESS OF GENDER, AGE, ETHNIC ORIGIN, AND NATIONALITY.
We look forward to hearing from you and exploring how you can contribute to our mission of improving lives through innovative medical solutions.
LI-DM2
Responsibilities:
YOUR ROLE
Based in Middelfart, you will join our Global Quality Department and report to the Vice President of Global Quality, Diagnostics. As a Regulatory Affairs Specialist, you will take ownership of regulatory affairs for selected product areas, ensuring adherence to current regulatory standards, as well as represent regulatory affairs in product development projects, collaborating closely with our regulatory compliance department.
Your job will also involve creating and maintaining regulatory documentation, ensuring alignment with product registration teams, and providing regulatory assistance to Customer Service and other stakeholders.
Finally, you will collaborate with cross-functional teams to integrate regulatory requirements into business processes.
KEY RESPONSIBILITIES
- Execute regulatory classification and strategy for selected product areas.
- Represent regulatory affairs in product development projects,and work close together with our regulatory compliance department.
- Create and maintain regulatory documentation.
- Ensure alignment with the team handling product registrations.
- Provide regulatory assistance to Customer Service and other stakeholders.
- Collaborate with cross-functional teams to integrate regulatory requirements into business processes.
REQUIREMENT SUMMARY
Min:2.0Max:4.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
5500 Middelfart, Denmark