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Pride Health · 22 hours ago

Regulatory Affairs Consultant

United States

Contract

Remote

Senior Level

5+ years exp

Pride Health is seeking a remote Regulatory Affairs Consultant for a medical device manufacturer specializing in various health solutions. In this role, you will lead regulatory affairs on cross-functional teams for drug products, conduct regulatory assessments, and support global regulatory strategies.

Health CareHuman ResourcesInformation Technology

Growth Opportunities

Hiring Manager

Rob Van Riet

Responsibilities

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

Supporting global regulatory strategies for changes related to post-market changes

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 change projects (directly for USA)

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 AffairsRegulatory SubmissionsRegulatory StrategiesStakeholder ManagementInternational Submission SupportProject ManagementCross Functional Project ManagementRegulatory AcumenOffice SuiteRegulatory Management Software

Required

Bachelor's Degree in scientific discipline (e.g. Chemistry, Chemical Engineering) or higher AND minimum five (5) years of experience in regulatory affairs in the drug (pharmaceutical), and medical device industry with experience working on combination medical devices

High School Diploma/GED from AND (10) years of experience in regulatory affairs in the medical device industry

Preferred

Direct experience authoring regulatory submissions/technical documentation

Direct experience authoring regulatory strategies and regulatory change assessments

Experience working with regulatory support for wound dressings and/or surgical products

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, drug products, proficient in Office Suite and Regulatory Management Software