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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 product compliance and global market authorizations, particularly within the medical device sector. Proven ability to lead teams, manage complex regulatory processes, and ensure adherence to standards such as ISO 13485 and MDSAP.
Highest-signal resume keywords
Regulatory Affairs LeadershipRegulatory Submissions PreparationISO 13485 ComplianceMDSAP Audit SupportMedical Device Regulatory Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Regulatory Submissions510(k) SubmissionsEU MDR SubmissionsRegulatory Strategy DevelopmentRegulatory AssessmentsData TrackingRegulatory Document CompilationRegulatory Decision-MakingRegulatory Data IntegrityProduct Compliance Management
Soft Skills
Stakeholder Relationship BuildingTeam DevelopmentCross-Functional CollaborationCommunication SkillsProblem-Solving
Tools & Technologies
Regulatory SystemsData Tracking ToolsRegulatory Compliance Software
Industry Keywords
Restorative Healing TechnologiesNegative Pressure Wound TherapyWound Care Medical DevicesAbsorbable Wound Care DressingsElectro-Mechanical DevicesEmbedded Software Medical DevicesTechnical Surveillance Audits
About the role
Key responsibilities & impact- Lead a regulatory affairs team primarily supporting the Restorative Healing Technologies portfolio
- Support early- and late-stage product development through critical milestones and regulatory activities leading to global product approvals
- Support ongoing product compliance throughout the device lifecycle
- Build strong relationships across stakeholders, management, and contract organizations
- Develop a team with the capacity and competence to support business strategic plans
- Develop and execute regulatory strategies for new product market authorizations, indications, and claims
- Manage complex regulatory decision-making among cross-functional stakeholders
- Represent Regulatory Affairs in global business and functional strategic meetings and forums
- Perform regulatory assessments and determine registration plans with the business
- Articulate global registration requirements and compile regulatory documents according to local requirements
- Submit registration documents and follow through on evaluations until regulatory authorization is obtained
- Act as the focal point for commercial support related to regulatory activities
- Manage regulatory systems and tools, data tracking, and regulatory data integrity
- Review advertising and promotional materials for alignment with cleared claims
- Monitor new regulations and provide regulatory information, updates, and documentation
- Support ISO 13485, MDSAP, and Technical Surveillance audits
- Complete additional duties, responsibilities, or assigned projects
Requirements
What you’ll need- Bachelor’s Degree or higher (completed and verified prior to start) AND seven (7) years of Regulatory Affairs experience within a regulated industry in a private, public, government or military environment OR High School Diploma/GED (completed and verified prior to start) AND eleven (11) years of Regulatory Affairs experience within a regulated industry in a private, public, government or military environment
- Master’s Degree or higher in a scientific, engineering, regulatory, or quality discipline
- Three (3) years of experience preparing and/or supporting regulatory submissions, including 510(k) submissions, EU MDR submissions, or other international medical device regulatory submissions
- Three (3) years of experience supporting ISO 13485 and/or MDSAP audits
- Experience supporting regulatory activities for negative pressure wound therapy devices and/or wound care medical devices
- Experience supporting regulatory activities for absorbable wound care dressings and matrices
- Experience supporting regulatory activities for electro-mechanical devices and/or embedded or stand-alone software medical devices
- Must be legally authorized to work in country of employment without sponsorship for employment visa status
Benefits
Comp & perks- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits
- Up to 10% domestic/international travel opportunity