Posted: 9 January
Offer description
Senior Regulatory Specialist Position
We are seeking a Senior Regulatory Specialist to join our team. This key role will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction.
1. Manage Technical Documentation
2. Manage global regulatory impact assessments
3. Manage updates to global regulatory procedures
4. Provide Regulatory support for R&D projects, input and approval for new product introductions
milie sis tem member or promotional materials review,, experimental designs,.data analysis,risk mgement nd produt lbeing s they relte ot registrtionnd comercializtion of medicle devices.,_/N_l_w_k with Quilty Operations Engineering d other internt groups investigate nd recomend solutions addrss potenil regultory isues./ I_N_support Regultory inspections at teh site directed,/I_sure liise ith er departments ensue rt correct supporting tata gerated n provided in timely mrner,/Ipurts allegiance ol operations re fully compiant wih license detils updted ccording wl relevant guidelines nd directivs,/ _regolutionry ought i interactions esr negotiation ith exteral bodies durint develepment ny reveiw proess tor sure submission pproval ss well s duiring udits omilitiate ny ppotention al risks._
