Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives.

How you’ll make an impact:

Prepare and complete product registration tasks covering the new product registration, the registration amendment, and the renewal registration. Ensure product tests/samples meet safety and performance requirements of regulatory agencies in collaboration with lab techniciansPrepare clinical trial and evaluation report applications according to government regulations, hospital ethics committee needs, and company requirements for submissionCreate local language labels and Instruction For Use in compliance of country regulations before passing them to Supply ChainLiaise with regulatory agencies to facilitate and expedite review and approval of company products, registrations, submissions, reformulations etcMaintain proper records in the Module Change Request and JDE system to comply with local and company regulatory and quality requirementsServe as regulatory liaison throughout product lifecycle. Participates in regulatory strategy and operating plansHandle product recall reporting to regulatory agencies, for products exhibiting non-complianceReview marketing advertisements to ensure compliance to regulations and submit to FDA for approvalOther incidental duties; Serve as regulatory representative to sales & marketing team, clinical team and regulatory agencies

What you'll need (Required):

Bachelor's Degree or equivalent in related field, 3 years experience previous related experience Required orBachelor's Degree or equivalent in scientific discipline (e.g., Biology, Microbiology, Chemistry)Experience in preparing domestic and international product submissions PreferredOther: Coursework, seminars, and/or other formal government and/or trade association training Required

What else we look for (Preferred):

Proven expertise in Microsoft Office Suite including Word, PowerPoint and ExcelGood written and verbal communication skills and interpersonal relationship skillsGood problem-solving, organizational, analytical and critical thinking skillsSolid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devicesSolid knowledge and understanding of global regulatory requirements for new products or product changes.Solid knowledge of new product development systemsStrict attention to detailAbility to interact professionally with all organizational levelsAbility to manage competing priorities in a fast paced environmentWork is performed independently on complex projects and/or lines of work and reviewed for accuracy and soundnessAdhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control