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SOLVENTUM · 2 months ago

Senior Regulatory Affairs Specialist (Remote: United States)

United States

Full-time

Remote

Senior Level

$137K/yr - $168K/yr

5+ years exp

Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. In this role, you will act as the lead Regulatory Affairs associate on strategic cross-functional teams for continuity projects related to the 3M & Solventum spin-off for the Medical Surgical business.

Business Consulting and Services

No H1B

Responsibilities

Conducting global regulatory change assessments and coordinating associated activities for assigned products

Supporting global regulatory strategies for changes related to spin-off continuity projects and ensuring these strategies are integrated with the overall RA spin-off plans

Demonstrating operational and strategic mindset that is results-oriented with a strong bias towards executing with speed, agility, and quality

Demonstrating excellent organizational, prioritization, oral and written communication skills

Providing regulatory review of technical reports and documents

Providing contributions for development and implementation of regulatory processes

Documenting and managing metrics

Leading regulatory filings as needed for continuity projects (directly for EU/USA, Canada and supporting ROW)

Supporting risk management activities, vigilance reporting activities, and other quality related initiatives with minimal oversight

Communicating results of technical tasks to teams, respective business group(s) and/or country/region served via reports, standards and/or presentations

Leading the implementation of key corporate initiatives and appropriate tools

Qualification

Regulatory AffairsMedical DevicesRegulatory SubmissionsStakeholder ManagementRegulatory StrategiesProject ManagementOffice Suite ProficiencyRegulatory Management SoftwareCross Functional CollaborationCommunication SkillsOrganizational Skills

Required

Bachelor's Degree or higher in a science or engineering discipline (completed and verified prior to start) AND five (5) years of experience in regulatory affairs in the medical device industry in a private, public, government or military environment

High School Diploma/GED AND nine (9) years of experience in regulatory affairs in the medical device industry in a private, public, government or military environment

Preferred

Experience working on combination medical devices with an antimicrobial

Direct experience authoring regulatory submissions/technical documentation

Direct experience authoring regulatory strategies and regulatory change assessments

Experience working and providing regulatory support for new product development teams

Experience developing regulatory strategies, label and claims review and project management

Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devices, proficient in Office Suite and Regulatory Management Software