In this role you will provide Regulatory Affairs technical support for product development and sustaining engineering, including compliance with international standards and regulations. You will be a key contributor to US and International Regulatory registrations and work closely with the R&D and Operations groups at RefleXion, learning all about a novel imaging/radiation therapy device. This role requires onsite working 1-2 days per week.
- Assist and work with QA and R&D for Regulatory input on product development processes such as system requirements, risk management, design reviews, and change management of released products.
- Develop the standards compliance strategy for company products, define product-related requirements and support activities required to maintain regulatory compliance as new or revised versions of standards are released.
- Maintain expertise in domestic and international regulations and standards, with a focus on relevant medical devices. Research and analyze state of the art regulatory requirements related to software, cybersecurity, and other relevant topics.
- Support the Regulatory team with the registration packages they prepare.
- Assist with inspections, audits, testing by regulatory/third party assessors.
- Aid in post-market product surveillance investigations as needed, especially for potential standards non-compliance.
- Other duties as assigned.
- Bachelor’s Degree in technical field
- Minimum 3 years of compliance-focused education and/or experience working within medical device manufacturing quality management systems
- Strong familiarity with IEC 60601 family of standards
- Strong familiarity with 21 CFR Part 820 and/or ISO 13485
- Must have contributed to successful preparation and submission of FDA 510(k), Pre-market Application (PMA), or international registrations for medical devices
- Experience in Design Controls
- Reliable self-motivated, with leadership experience
- Strong communication skills - both written and verbal
- Graduate Degree in related field is highly desirable and preferred
- Experience with IEC 62304 software standard, and cybersecurity guidance and regulations preferred
- Experience with European Union Medical Device Regulations (EU MDR) Technical files preferred
Company Benefits and Perks – What you will love about us!
All positions at RefleXion are eligible to receive the same benefits, listed here. We also want to highlight the following perks that add to our collaborative and team-work company culture. As we continue to grow as a company, we strive to have these benefits and perks grow with us – we are so excited for what is in store!
- The opportunity to work with a passionate, driven team in a pre-IPO start-up environment
- Competitive compensation and stock option package
- Three (3) weeks PTO to start
- Medical (both HMO and PPO options), Dental and Vision
- Health Savings Account (HSA), Flexible Spending Account (FSA), Dependent Care Flexible Spending Account (DCFSA)
- Employee Assistance Program (EAP)
- Employer paid Life Insurance
- RefleXion Benefit Hub – for company exclusive discounts and deals on a variety of sites and items
- Daily on-site lunches
- Kitchens filled with a variety of healthy and delicious snacks and drinks – including espresso and soda machines!
- Company culture building events such as Coffee Chats with the Executives, Friday Afternoon Ice Cream Socials and monthly Book Club
- On-site mobile car wash services weekly
- Electric car charging stations on site