Johnson & Johnson
Technical Writer - Reg. Affairs & Production Interconnect
Location: JnJ Groningen, Fully remote job.
Language: English is a must, Dutch a nice to have
Working hours: 32 hours or 40 hours possible
Contract: the first contract for 6 months, probably extended for another 6 months but not guaranteed yet, depends on business need and performance.
No perspective for a perm contract as project-related
Focus on: document writing for products in medical devices (e.g. intraocular lenses,…)
· Plan, write, and review technical documentation under Design Control.
· Conduct technical reviews to ensure document accuracy and compliance to local procedures, Johnson & Johnson guidelines, and regulatory requirements.
· Partner with cross-functional team members to define the impact of regulatory requirements and industry trends/practices.
· Manage daily activities to ensure timelines are met.
Experience and Skills:
· Related job experience with an advanced degree is required.
· Experience within the medical device industry and knowledge of MDR regulatory requirements is preferred.
· Strong verbal and written communication skills and interpersonal relationships are required.
· Demonstrated knowledge and experience in quality regulatory compliance, adverse event reporting, medical device risk management processes, and common statistical methods are preferred.
· Regulatory/Notified Body audit experience is preferred
4-6 years of experience as a technical writer in the field of medical devices
BA, BS, or BSN is required in areas of Engineering, Biomedical Engineering, or other life science discipline. An advanced degree is preferred.