Regulatory Affairs support

Responsible for regulatory planning for new product introductions and product changes and assist in maintaining regulatory compliance.Plan, generate and coordinate regulatory submissions for product/ solution licensingMaintain existing regulatory filings/ licenses, managing updates and related changes control processes.Assists with implementation of global regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.Develop regulatory strategy and if needed connect to regulatory SME's and make regulatory planProactive stakeholder management with business/ manufacturerDevelops and facilitates regulatory submissions for new products/ solution, existing products/ solutionsOther regulatory projects as applicable.1-2 years of experience in the medical device industryAbility to understand regulatory environmentAbility to understand compliance rules, guidelines and regulationsAbility to partner with other areas of the companyExperience in assembling the technical documentAbility to interpret applicable regulations to ensure compliance in a changing regulatory landscapeAbility to work in a matrix organization and being agileStrong organizational skills, ability to work on multiple projects and work effectively in a demanding time sensitive environment