Director of Trade Compliance at Blue Origin providing leadership and oversight for trade compliance in aerospace. Driving compliance strategy while ensuring alignment with business objectives and international operations.
About the role
- Senior Regulatory Affairs Specialist at PROCEPT BioRobotics focusing on regulatory strategy for medical devices. Lead regulatory submissions and support compliance in innovative surgical robotics.
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 company’s 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.
Requirements
- Bachelor’s degree, in scientific or engineering field preferred
- Five (5)-plus years work experience in medical device field
- Minimum of 5 years’ 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
Benefits
- full medical coverage
- wellness programs
- on-site gym
- 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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