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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory strategy and compliance for medical devices, including experience with U.S. FDA and international regulations. Proficient in managing regulatory submissions, audits, and inspections while collaborating effectively with multidisciplinary teams.
Highest-signal resume keywords
Regulatory StrategyU.S. FDA ExperienceRegulatory SubmissionsRAC CertificationISO 13485 Familiarity
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 RequirementsDocumentation CoordinationRisk ManagementProduct Development SupportChange Control ActivitiesRegulatory Impact AssessmentTracking Systems MonitoringMedical Device Lifecycle ManagementAudits SupportInspections Support
Soft Skills
Strong Written CommunicationStrong Verbal CommunicationOrganizational SkillsCross-Functional CollaborationPriority Management
Certifications & Qualifications
RAC Certification
Industry Keywords
EU MDRMDDISO 14971Notified BodiesGlobal Regulatory Agencies
About the role
Key responsibilities & impact- Partner with multidisciplinary teams to communicate regulatory requirements and support regulatory strategy
- Provide regulatory input to product development, lifecycle planning, and change control activities
- Assess the regulatory impact of proposed design, labeling, manufacturing, and process changes
- Prepare, review, and coordinate documentation for regulatory submissions, renewals, registrations, and related filings
- Support audits, inspections, and regulatory authority interactions
- Participate in risk management activities and address regulatory considerations
- Monitor and support tracking systems for regulatory deliverables and documentation
- Stay current on applicable regulations, standards, and guidance documents
- Collaborate with internal stakeholders to resolve issues, manage priorities, and keep regulatory activities on track
- Contribute to process improvements and strengthen regulatory practices
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 are eligible for paid sick time, as required under applicable state law
- Equal employment opportunity and reasonable accommodations for qualified individuals with disabilities