Position: Regulatory Affairs Specialist
Rate of Pay: $45,000.00 - $55,000.00 per year
Employment Type: Full Time; Temp to Hire
Create and maintain procedures, reports, and status updates related to medical device regulatory affairs. Ensures compliance with US, EU, HC, and international regulatory requirements. Support the Sales, Marketing, and Engineering departments by providing regulatory assessments of registrations, submissions, and related projects.
Essential Duties and Responsibilities
- Create and maintain procedures and reports including Clinical Evaluation Reports, Post Market Surveillance.
- Create and maintain Design History Files and Technical Files in collaboration with others.
- Provide device submissions and registrations support.
- Determine submission and registration requirements for medical devices in different countries.
- Conduct change impact assessment associated with design changes of approved medical devices.
- Comply with Medical Device Directive, Medical Device Regulation, ISO 13485 and 21 CFR 820.
- Organize all market registrations and renewals and maintain/update as necessary. Create a user-friendly matrix with registration and renewal requirements for the US, Europe, Australia, Brazil, Canada, Japan, and other countries.
- Communicate with the domestic and international sales team and regulatory parties to facilitate their inquiries.
- Collaborate with other functional areas to facilitate effective regulatory response.
- Ensure compliance with the US and appropriate international regulatory requirements.
- Other responsibilities include ownership and/or contribution in
- Risk Management initiatives including dFMEA and pFMEA creations/updates, clinical evaluation protocols/reports, and post-market surveillance reports.
- Design and process control initiatives for new products, design changes, and existing process optimizations.
- MDSAP and other audits and proactively implement/recommend improvements.
- Organize regulatory documents and maintain/update to keep up to date (with changes such as line extensions and letter to file).
- Minimum of BA/BS Degree in life sciences including pharmacy/engineering/or equivalent.
- A minimum of 2 years of regulatory experience with a bachelor’s degree or 1 year of experience with a master’s degree.
- Ability to communicate complex ideas clearly and simply both orally and in writing.
- Demonstrated ability to effectively manage multiple projects and priorities.
- Team player with excellent interpersonal skills.
- Basic understanding of regulations associated with medical devices and/or IVDs.
- Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
- Experience with Class II medical device submissions is desired.
- Experience working directly with FDA, notified bodies and/or international health authorities is desired.
To apply or learn more about this opportunity, please email your resume to firstname.lastname@example.org or call our office at 520-323-3100. Please reference Order ID: 4CR8