Quality Assurance and Regulatory Expert
12 hours ago
About the Job
We are seeking an experienced Regulatory Affairs professional with more than 5 years of experience working with regulatory affairs in the European region. Knowledge and proven track record in Regulatory Affairs for Medical Devices in the European region are essential. A degree equivalent in an engineering-related subject or a formal engineering apprenticeship with demonstrated experience in a similar role is required.
In this role, you will be responsible for:
- Supporting, creating, and maintaining the Regional Submission Process(s) and Regulatory Roadmap for the European region.
- Informing and supporting local organizations regarding changes in legislation, providing interpretation and strategic advice.
- Representing the company in interactions with international bodies in the field of regulatory submissions with a potential impact on business.
- Supporting locally appointed regulatory and quality staff in respective areas in their interactions with national authorities and in preparations of submissions and compliance data.
Benefits
We offer a range of benefits to support your career development and well-being, including:
- Up to 25 paid vacation days (UK), 30 paid vacation days/year (Sweden), plus bank holidays.
- A competitive salary and benefits package, including private medical insurance and an attractive employer pension contribution package.
- A hybrid work option requiring at least 3 days on-site per week.
- Cycle to work scheme, Life Assurance, and Onsite subsidized restaurant.
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