Medical Devices - Regulatory Scientist/Senior Regulatory Scientist

About the Opportunity

In this Regulatory Scientist/Senior Regulatory Scientist - Medical Devices role, responsibilities include:

Primary focus on Medical Devices and Combination Products

• Participate in development plans for Medical Devices and assimilated products (manufacturing and controls, non-clinical, clinical, market access)
• Participate in regulatory strategy, positioning, and roadmaps for Medical Devices
• Write, review and assemble high-quality regulatory submissions for medical devices, including combination products regulated as medical devices, such as CE marking dossier and Clinical Trial Application (CTA) dossier/Investigator's Brochure (IB) for clinical trials
• Participate in Premarket Approval Application (PMA), Premarket notification (510k), De Novo submission, and Investigational Device Exemptions (IDEs)
• Participate in other relevant projects of the product line such as regulatory strategy, positioning and roadmaps, and client training
• Ensure compliance of deliverables with US, EU, or other territory regulations and applicable guidelines, including ICH; ensure all communications to the FDA/Health Authorities, both formal and informal, meet internal and external standards of quality and format
• Communicate clearly with clients and regulatory authorities for assigned projects
• Monitor, prioritize and supervise project strategy, timelines, and milestones – communicate these to the project team members

Potential opportunities to work on other projects

• Contribute to the execution of successful projects on medicinal products, diagnostics, and medical devices for Health Tech products: Patient engagement strategy, including clinical decision support (CDS) software that qualify as a Software as a Medical Device
• Comply with guidance from the International Medical Device Regulators Forum (IMDRF)
• Conduct a targeted and systematic literature review
• Identify and communicate potential risks and solutions
• Facilitate and foster relationships with stakeholders such as patient associations, ARS, and government organizations

Requirements

The ideal candidate will possess the following qualifications:

Experience

• Knowledge of Medical Devices/Combination Products as demonstrated through a combination of work experience and academic background.
• Focused experience with 510(k)’s, De Novos, IDE’s, Q-Submissions, PMA’s, and HDE’s; experience with pre-IND’s, NDA’s, and BLA’s as it pertains to medical devices and combination products; preferred experience includes: IVD-CDx, patient engagement, and Software as Medical Device
• Good understanding of the medical device development process
• Prior experience in medical devices, biotech, or related life sciences industry
• Prior experience with regulatory submissions and interactions with the FDA and other regulatory agencies is a plus
• Prior experience directly interacting with the FDA/Health Authorities is a plus
• Experience in a consulting environment is a plus
• BS/BA degree in Life Sciences
• MS/MA/Ph.D. degrees are a plus
• Certification: RAC is a plus

Personal attributes and skills

• Strong writing and communication (written and verbal) skills.
• Strong attention to detail, organization/multitasking, project management (planning, scheduling, documentation, project control), and teamwork skills.
• Consulting skills: influencing, advising, facilitating, diplomacy, critical thinking, adaptable, and presenting
• Problem-solving abilities and a self-starter.
• Professional and courteous work demeanor. A relationship builder with colleagues, clients, and regulatory authorities.
• Ability to work under deadlines to meet project timelines, including the ability to modify work schedule when needed.
• Computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint), and Adobe Acrobat.
• Maintains company values (People, Innovation, Passion, Excellence) and demands the highest standards of conduct from self and others.

Additional Information

• Equal Opportunity Employer
• All resumes are held in confidence
• Must be eligible to work in the US

Benefits

• Health Care Insurance plans (Medical/Dental/Vision)
• FSA and company-funded HRA plans
• Retirement Savings Plan (401k plan with company safe harbor matching contributions
• Paid Time Off (Vacation/Sick/Company Holidays)
• Group Term Life/AD&D,Short Term Disability, and Long Term Disability insurance