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MediBeacon Inc. · 1 day ago

Regulatory Lead

St Louis, MO

Full-time

Hybrid

Senior Level, Lead/Staff

8+ years exp

MediBeacon Inc. is a medical technology company focused on advancing fluorescent tracer agents and transdermal detection technology. The Regulatory Leader will ensure compliance with regulatory requirements, develop regulatory strategies, and collaborate with cross-functional teams to meet all relevant guidelines throughout the product lifecycle.

BiotechnologyHealth CareMedical DeviceReal Time

Responsibilities

Hands-on management of medical device and combination product projects to ensure global regulatory compliance

Develop and execute regulatory strategies and plans to ensure compliance with applicable laws, regulations, and standards

Stay updated on changes in regulatory requirements and translate them into actionable steps for the organization

Collaborate with cross-functional teams including R&D, Quality Assurance, Clinical, and Legal to ensure that all regulatory requirements are met throughout the product lifecycle

Prepare and submit regulatory submissions, including but not limited to, product registrations, pre-market approval submissions, de novo, IDE, IND, annual reports and post-market surveillance reports

Liaise with regulatory authorities and act as a contact during inspections, audits, and regulatory agency interactions

Conduct risk assessments and develop mitigation strategies to manage regulatory risks

Review and approve product labelling, promotional materials, and other relevant documentation to ensure compliance with regulatory requirements

Provide regulatory guidance and support to internal stakeholders, including product development teams, to ensure that regulatory requirements are incorporated into the development process

Executes projects in compliance with regulatory requirements and Phase Gate review discipline

Supports commercial launch activities for new products

Qualification

FDA regulationsRegulatory strategy developmentMedical device experienceInternational quality standardsRegulatory submissionsAnalytical skillsCollaboration skillsCommunication skillsProject management

Required

A minimum of a Bachelor's degree in a scientific discipline

A minimum of at least 8 years' experience in medical device and combination program leadership is required

Expert in FDA and global regulatory guidelines with experience interacting with regulatory authorities within the medical device industry and pharmaceutical environment

Demonstrate effective planning, budgeting, and influencing skills

Possess strong knowledge of international quality and regulatory requirements associated with MediBeacon projects

Have strong collaboration, team building and development skills

Possess effective analytical and problem-solving skills

Be very well organized and have a strong ability to manage multiple projects simultaneously

Strong written, verbal and presentation skills, including accomplished public speaking skills with the ability to present, persuade and convince regulators, investors and key opinion leaders with respect to the Company's products and strategies

“Hands-on” experience. Proactive and “can do” attitude

Be a high energy and results-oriented individual who is mature and successful in a business environment and is skilled in motivating and inspiring people