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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory strategies and submission processes for medical devices, including familiarity with U.S. FDA and international regulatory requirements. Strong organizational and communication skills are essential for managing multiple projects and collaborating with cross-functional teams.
Highest-signal resume keywords
Regulatory Submission ExperienceU.S. FDA KnowledgeEU MDR FamiliarityRAC CertificationCross-Functional Collaboration
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory StrategiesDocument PreparationRegulatory ComplianceQuality Documentation ReviewProject ManagementRisk AssessmentSubmission TrackingMedical Device Lifecycle ManagementAudit SupportRegulatory Requirements Analysis
Soft Skills
Strong Communication SkillsOrganizational SkillsAbility to Manage Multiple Priorities
Certifications & Qualifications
RAC Certification
Industry Keywords
Medical DevicesISO 13485ISO 14971Notified BodiesGlobal Regulatory AgenciesHealth Authority InquiriesRegulatory AuditsSubmission ProcessesRegulatory GuidelinesCross-Functional Teams
About the role
Key responsibilities & impact- Support international regulatory strategies and submission activities across global markets
- Assist with new product registrations, renewals, amendments, and country-specific regulatory requirements
- Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections
- Compile materials for global submissions, license renewals, amendments, and responses to health authority inquiries
- Assess regulatory requirements and help recommend submission strategies based on business needs, risk, and timelines
- Support critical, complex, and time-sensitive registrations
- Review regulatory, technical, quality, labeling, and product documentation for completeness, accuracy, and consistency
- Manage multiple projects while tracking deadlines, action items, and submission status
- Identify regulatory risks, gaps, and delays and escalate issues as needed
- Communicate regulatory requirements to internal and external stakeholders
- Stay current with regulatory procedures, guidelines, and global requirement changes
- Maintain awareness of evolving global regulatory requirements and communicate updates to internal teams
- Identify opportunities to streamline submission processes, trackers, and cross-functional ways of working
- Collaborate with regional regulatory colleagues and Quality, Clinical, Manufacturing, and Marketing teams
- Support global submissions across Asia Pacific, the Middle East and Africa, Latin America, Canada, and EMEA
Requirements
What you’ll need- Bachelor’s degree required
- Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience
- Unrestricted U.S. work authorization at the time of hire and for the duration of employment
- Experience with U.S. FDA and international regulatory requirements for medical devices
- Familiarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standards
- Experience supporting regulatory submissions, audits, or inspections
- Strong written and verbal communication skills
- Strong organizational skills with the ability to manage multiple priorities
- Experience collaborating in a cross-functional, fast-paced environment
- Familiarity with medical device product development or lifecycle management
- RAC certification or progress toward certification
- Experience working with Notified Bodies or global regulatory agencies
- For Baccalaureate degrees earned outside of the United States, a degree satisfying 8 C.F.R. § 214.2(h)(4)(iii)(A) is required
Benefits
Comp & perks- Competitive Salary and flexible Benefits Package
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
- Temporary employees: paid sick time, as required under applicable state law
- Temporary employees: Employee Stock Purchase Plan