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Senior Regulatory Affairs Engineer
il y a 1 mois
About the Role:
We are seeking a highly skilled and experienced Senior Regulatory Affairs Engineer to join our dynamic and distributed team at Eko Devices. As a Senior Regulatory Affairs 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.
In this role, you will work on diverse tasks with different stakeholders, ranging from collaborating with and providing regulatory guidance to cross-functional teams throughout the product lifecycle to the preparation and submission of regulatory filings. You will plan, lead, and execute regulatory activities and decisions to ensure proper documentation and tracking.
Responsibilities:
- Collaborate with and provide regulatory guidance to cross-functional teams during product development, manufacturing, and post-market surveillance to ensure compliance with applicable regulations and standards.
- Provide regulatory input during design reviews, risk assessments, and change management processes.
- Develop and maintain regulatory documentation, including Design History File (DHF), Technical Documentation, and Risk Management Files as well as Device Master Record (DMR) and Device History Records (DHR).
- Prepare, review, and submit regulatory submissions for different markets.
- Respond to inquiries and requests from regulatory authorities and agencies and manage communication for specific questions.
- Plan, lead, and execute regulatory activities and decisions to ensure proper documentation and tracking.
- Stay current with changes in global regulatory requirements and communicate these changes to relevant stakeholders.
Requirements:
- 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, UK MDR, ISO 13485 and other relevant regulatory standards.
- Extensive experience with regulatory submissions for different international markets.
- Background in medical device development in general and agile software development in particular.
- Effective communication skills (written and verbal) and teamwork abilities, essential for our remote-first environment.
- Exceptional analytical and problem-solving skills.
- A product mindset, with a solid understanding of user needs and product lifecycle.
About the Engineering Team:
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 without sacrificing everything else.
Organization and Way of Working:
The engineering team is divided into smaller cross-functional project teams that each focus on a specific goal or target. We strive to create groups that are cross-functional and able to complete their goals without dependence on other teams. We have a bi-weekly engineering demo where groups present their progress or failures or hacks.
