Senior Regulatory Affairs Engineer
il y a 5 jours
We are seeking a highly skilled and experienced Senior RA Engineer to join our dynamic and distributed team at Eko Devices. As a Senior RA Engineer, you will play a crucial role in ensuring that our medical devices are developed, manufactured, distributed, and maintained in compliance with relevant regulations and standards.
Responsibilities- Collaborate with cross-functional teams to ensure compliance with applicable regulations and standards, such as FDA, EU MDR, and ISO 13485.
- Provide regulatory input during design reviews, risk assessments, and change management processes.
- Develop and maintain regulatory documentation, including Design History File, Technical Documentation, and Risk Management Files.
- Prepare, review, and submit regulatory submissions for different markets.
- Respond to inquiries and requests from regulatory authorities and agencies.
- Stay current with changes in global regulatory requirements and communicate these changes to relevant stakeholders.
- Established commercial experience in Regulatory Affairs roles within the Medical Device industry.
- Deep understanding of regulatory compliance principles and activities.
- Deep knowledge of FDA regulations, EU MDR, and ISO 13485.
- Extensive experience with regulatory submissions for different international markets.
- Background in medical device development and agile software development.
- Effective communication skills and teamwork abilities.
- Exceptional analytical and problem-solving skills.
We are a distributed and remote-first company with a team of 40 full-time engineers working from various locations across Europe. Our headquarters and hardware development team are based in Stockholm, Sweden. We are a flexible workplace that focuses on work/life balance and strongly believe in our mission.
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il y a 2 semaines
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il y a 1 mois
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