Senior Regulatory Affairs Specialist

Mission: Create solutions as part of the Epitel product development teams through the application of Regulatory Affairs skills for medical devices. Play an active role from product inception through product launch and maintenance, ensuring that products meet all design control and regulatory requirements. Develop regulatory strategies and submissions to support the company’s growing profile of products in the US and in other regions. Support clinical trial efforts by providing Regulatory Affairs insights to trial planning and submissions.

Responsibilities:

• Develop regulatory strategies for the evolution of existing products and for future developments.
• Serve as a Regulatory Affairs subject matter expert providing appropriate regulatory input to new device and software development projects and to new and ongoing clinical trials.
• Manage, prepare, and submit regulatory submissions required for device approvals and registrations in the US and globally.
• Support communications with regulatory authorities.
• Support project labeling work, ensuring that product labels and instructions for use comply with product regulatory requirements.
• Work in tandem with Quality to understand regulatory requirements and standards that need to be met by Epitel and by its products.
• Maintain regulatory technical documentation.
• Provide leadership and guidance through product design and development phases.
• Conduct regulatory assessments of potential product changes to ensure ongoing compliance.

Qualifications:

• Problem solver with a strong background demonstrating strategic thinking and an ability to deliver on complex plans and strategies.
• Ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 820 and knowledge ISO 14971.
• Primary focus in US medical device regulatory affairs, with a strong preference for connected software devices and for electrical medical devices.
• Experience operating with IEC 62304 and IEC 60601 standards (and related collateral standards).
• Ability to provide input in a timely manner about customer needs and regulatory requirements to experienced teams using excellent verbal and written communication.
• 5-8 years of regulatory experience in medical device organizations.
• Bachelor’s or post-graduate degree, preferably in a regulatory, science, engineering, or related field of study.
• RAC or similar certification preferred.
• Capable of telling a complex product’s full story in a clear and concise manner.
• Detailed oriented, high energy, self-starter, who exercises sound judgment and delivers against both personal and company business goals and objectives

Role-based competencies

• Ethical, honest, committed, strong moral compass
• Detailed, focused, organized, able to understand complexity
• Clear communicator, able to simplify challenging topics, persuasive, comfortable working in a team
• Willingness to say no and, conversely, willingness to help identify solutions
• Able to handle questions and controversies without becoming confrontational
• Dedicated to their team, experienced regulatory leader
• Versed in regulatory practices and policies within a quality system
• Consistently applies technical principles, theories, concepts and regulatory best practices

Values

• Act with integrity and assume good intent - We’re as proud of how we’re building as we are of what we’re building. We do the right thing, follow through, and look out for each other. If someone’s stuck, we reach out and help them grind. We’re a team.
• Give a damn - We do what we do because we’re committed to the cause - working for the next patient, the next caregiver. We listen to patients, their families, their doctors, and build to their needs. We take ownership of that responsibility, our work, and we commit to the mission.
• Debate ideas, not personalities - Everything we’ve done has been for a reason, but precedent does not equal best practice. We constantly challenge our own ideas while respecting our team’s contributions and competence.
• Exceptional changemakers - We have to be exceptional - for patients, caregivers, and ourselves. We hold ourselves and each other to the highest standard. We step up to take ownership, leadership, and we follow through. We hire specialists who do the same.
• Lean into the turn - Healthcare is in constant change. In turn, we constantly accept feedback and change with it. We’re flexible, agile, creative, and we lean into it.
• Perpetual growth -