Support Research and Development programs with regulatory strategy development for worldwide product registration
Author and prepare regulatory submissions for new products
Collaborate with Regulatory Affairs Team members and cross-functional partners
Prepare regulatory strategies/plans taking inputs and incorporating compliance requirements
Provide ongoing support to product development teams for regulatory issues
Negotiate with regulatory agencies as needed
Participate in project team meetings to plan strategies
Provide mentorship, training, and support to junior members of the department
Assist regulatory department in the update and creation of internal policies and procedures

Requirements

Bachelor’s degree in a technical discipline
Minimum 4 years of medical device regulatory experience
Master of Science Degree (Nice to Have)
Experience working in regulated environments
In depth experience with FDA requirements, guidance documents, Medical Device Regulation, ISO 14971, ISO 13485
Direct Regulatory Affairs experience supporting programs throughout software development life cycle
Direct experience authoring and successful approval of regulatory submissions for Class IIb /III/IV medical devices
Strong negotiation skills and written/oral communication skills
Ability to support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
Proficient in MS Office, MS Project, Adobe Acrobat and Agile

Benefits

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategy developmentregulatory submissionsFDA requirementsMedical Device RegulationISO 14971ISO 13485software development life cycleauthoring regulatory submissionsmedical device regulatory experiencenegotiation

Soft Skills

mentorshiptrainingcommunicationproject managementprioritizationcollaborationsupport multiple projectsfunction on a global basisconduct team meetingsmeet project deadlines

Certifications

Bachelor’s degreeMaster of Science Degree