Job Description:
• Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator.
• Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals.
• Prepares and submits regulatory information required to obtain global market access.
• Write and file FDA submissions (e.g., Q-submissions, IDEs, 510(k)s).
• Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams.
• Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status.
• Guide conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.
• Assists in the development and enhancement of Regulatory Affairs processes.
Requirements:
• Minimum of a Bachelor's Degree required
• Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required
• Experience with Class II medical device regulatory product submissions required
• Previous experience with health authority meetings/interactions required
• A demonstrated track record of developing and driving implementation of regulatory strategies.
• Working knowledge of Cybersecurity regulations, requirements for software as a medical device, including devices with AI/ML.
• Working knowledge of requirements for medical devices that include electronic components and associated testing (IEC 60601).
• Excellent communication skills for effective collaboration with cross-functional partners.
• Strong attention to detail.
• Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.
Benefits:
• Pension and savings plan (401(k))
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year