Senior Regulatory Affairs Specialist
About The Position
Are you ready to embark on an exciting journey that will revolutionize the way men suffering from BPH are treated? Join us as a Senior Regulatory Affairs Specialist and be at the forefront of regulatory science for medical robotics. Your mission? To support a deep culture of compliance while advocating for breakthrough medical innovations in the space of urological surgery. Youâll be providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class II and III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies.
Requirements
- Bachelorâs degree, in scientific or engineering field preferred
- Five (5)-plus years work experience in medical device field
- Minimum of 5 yearsâ experience working in regulatory affairs in a medical device company
- Knowledge of Title 21 of the US code of Federal Regulations (21 CFR 800-1299)
- Experience with US Federal Food, Drug, and Cosmetic Act (FD&C) Section 510(k)
- Experience with European Medical Device Directive (93/42/EEC with 2007/47/EC) and EU Medical Device Regulation 2017/745
- Experience with Quality Management System Standard ISO 13485 is required
- Experience working cross-functionally with engineering, marketing, manufacturing, and legal teams to facilitate completion of labeling and artwork assignments
- Excellent written communication skills, especially with technical information
- Proficiency in Microsoft Office Suite preferred
- Precise, thorough and analytical
- Proactive and adaptable to a fast-paced work environment, including managing multiple projects simultaneously
Nice To Haves
- Advanced degree or credential in regulatory affairs preferred
- Hands-on experience maintaining Instructions for Use (IFUs), product labels, capital equipment documentation, and packaging labels in compliance with regulatory standards and internal labeling requirements
- Experience with e-labeling applications and/or content management system applications preferred
- Fluent in graphic design software and/or desktop publishing software
Responsibilities
- Lead regulatory labeling activities in support of global regulatory submissions for product registrations and variations.
- Lead authorship responsibilities for content within User Manuals, product inserts, and on-product labeling.
- Provide SME input on global regulatory labeling requirements and standards. Apply style guidelines and branding standards to new and modified product labeling. Verify that labeling complies with all applicable requirements
- Manage external service providers in designing graphic content for label artwork using design software, such as Adobe Illustrator, as well as dedicated labeling software, such as Bartender
- Create and revise label items within the companyâs document control system, by drafting and releasing engineering change orders
- Contribute to Labeling department process improvement initiatives
- Represent the Regulatory Affairs labeling function on project teams by collecting potential labeling inputs from other departments; interpreting the impact that projects, such as design changes, will have on labeling content; and implementing necessary modifications to the product labeling.
Benefits
- full medical coverage
- wellness programs
- on-site gym
- a 401(k) plan with employer match
- short-term and long-term disability coverage
- basic life insurance
- wellbeing benefits
- flexible or paid time off
- paid parental leave
- paid holidays
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
