Technical Writer - Regulatory Affairs & Production
*About PSC Biotech*
Who we are?
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
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.
Fully remote job
BA, BS, or BSN is required in areas of Engineering, Biomedical Engineering, or other life science discipline. An advanced degree is preferred.
English is required
Dutch is desirable but not required.
4-6 years experience as a technical writer in the field of medical devices
Training in regulatory affairs basics (desirable).
Understand context ISO11979
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. MDR: Medical devices regulatory - experience (pharma background) not from other industries
Knowledge design control
Job documentation with intraocular lenses
Not site, work from home, planning writing reviewing (reg. submissions, preparing data processing) Study Sticks
Contact communications, cross-functional related with a project manager and technical leader
Regulatory, clinical, and development
Statistical Analysis (training can be provided)
Defining the regulatory, long term mid-term planning strategic thinking (nice-to-have)
Attending, daily tasks: writing and reviewing the documentation (internal SOP & external - regu. agency, audits) - the technical description of the lens, use the right template (SME) technical deliverables are there.