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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs with a focus on Medical Device submissions, including developing regulatory strategies, managing complex data analysis, and ensuring compliance with global regulations. Proven ability to lead cross-functional projects and communicate effectively with regulatory agencies.
Highest-signal resume keywords
Regulatory Strategy DevelopmentMedical Device Regulatory SubmissionsData Analysis and Problem-SolvingCross-Functional CollaborationRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory SubmissionsClinical Data DevelopmentRegulatory StrategyGlobal Regulations KnowledgeProject ManagementRegulatory Affairs Process Best PracticesSubmission Data GatheringLabeling DevelopmentAudit SupportRegulatory Conformance
Soft Skills
Excellent Communication SkillsStrong Attention to DetailOrganizational SkillsAnalytical SkillsPresentation Skills
Certifications & Qualifications
RAC Certification
Industry Keywords
Medical DeviceFDANotified BodyHealth Authority InteractionsRegulatory ComplianceProduct DevelopmentLifecycle ManagementInternational RegistrationsPost-Submission CorrespondencePre-Submission Requirements
About the role
Key responsibilities & impact- Provide input and guidance during New Product Development and Lifecycle Management projects
- Develop regulatory strategy and supporting evidence, including clinical data
- Define, gather, and assemble information for regulatory submissions
- Prepare responses to regulatory agency questions and post-submission correspondence
- Communicate and negotiate with FDA and Notified Body reviewers
- Identify pre-submission requirements and align submission strategy
- Provide solutions to complex problems involving data analysis and intangible variables
- Lead submission of licenses and authorizations for existing product maintenance
- Support international registrations and dossiers
- Guide regulatory conformance in cross-functional projects, product development, claims, and labeling
- Collaborate on labeling development and approval
- Provide Regulatory Affairs support during internal and external audits
- Plan regulatory deliverable schedules and monitor projects through completion
- Assist in developing Regulatory Affairs process and system best practices
- Partner with other functions to define and obtain submission data
- Communicate business-related issues or opportunities to the next management level
- Ensure personal and Company compliance with applicable regulations, policies, and procedures
- Perform other assigned duties as needed
Requirements
What you’ll need- Minimum of a Bachelor's Degree required; desired areas of study include Science, Engineering, or related field
- Minimum of 6+ years of related Regulatory Affairs experience within Medical Device required (4+ years with Advanced Degree), or a combination of relevant experience
- Experience with medical device regulatory submissions for medium to high-risk devices required
- Demonstrated track record of developing and driving implementation of regulatory strategies
- Working knowledge of how global regulations impact product registration
- Excellent verbal and written communication skills
- Experience corresponding and collaborating with colleagues globally
- Ability to evaluate new regulatory requirements and regulatory changes and assess business impact
- Strong attention to detail
- Advanced analytical and problem-solving skills
- High organizational skills and ability to lead multiple projects/tasks simultaneously and prioritize effectively
- Strong learning and presentation skills for complex technology
- Ability to manage large, complex, and/or ambiguous information from multiple sources and make timely, effective decisions
- Ability to encourage and support internal collaboration across levels
- Ability to build and leverage internal and external networks
- Previous experience with health authority meetings/interactions
- RAC certification is a plus, not required
Benefits
Comp & perks- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation – 120 hours per calendar year
- Sick time – 40 hours per calendar year
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time – up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
- Hybrid Work
- Up to 15–20% travel