Lead Regulatory Affairs Specialist

• Execute regulatory strategies for product changes and/or new product development in alignment with company objectives.
• Participate in cross-functional project teams to advise on regulatory affairs related to bench animal and human clinical test plans reviewing and approving Design Control deliverables providing information and offering recommendations that reduce regulatory risks keep benefits and stay within specified timelines as project deliverables are understood and incorporated to the plan.
• Prepare regulatory documents and filings such as but not limited to Letters-To-File Pre-Submissions Investigational Device Exemptions 510(k)s Technical Documentation Files Notified Body submissions other international submission support as applicable and subsequent revisions/supplements and amendments by managing deliverables and timelines.
• Serve as the main point of contact to regulatory agency reviewers on submissions coordinate with internal team members to respond to deficiency questions in a timely manner and engage with regulatory agency reviewers for favorable outcomes.
• Leads multiple regulatory projects at one time and ensures objectives resources and deadlines are met.
• Review and approve Document Change Order requests CAPAs NCRs and other documents as applicable.
• Participate in regulatory operations e.g. establishment registration device listings UDI medical device license and certificate maintenance supporting customs requests etc.
• Participate in the development of procedures for the regulatory function and provide input to procedures owned by other functions as needed with a focus on both US and international compliance.
• Support the Operations teams and yield improvement projects.
• Provide regulatory documents (i.e. Letters to File Submissions to regulatory Agencies etc.) for management review.

• Bachelors degree in related field and a minimum of 8 years of experience in related roles at healthcare pharma or medical device industries; or an equivalent combination of education/training and experience.
• Primary authorship of US and/or OUS regulatory submissions and change order regulatory assessments.
• Advanced degree or strong regulatory affairs experience in medical device industry strongly preferred.
• High level of expertise in Vascular space is preferable.
• EU MDR MDSAP experience a plus.
• Strong expertise preparing US and/or OUS regulatory submissions and change order assessments.
• Excellent written and oral communication skills; technical writing capabilities are a must.
• High level of expertise in attaining deliverables through successful project/documentation management and organizational skills.
• Ability to exercise independent judgment and decision making for complex situations/programs.
• RAC certification a plus.
• Independent yet able to work in a team; detailed approach to work assignments; high standards for quality of work and able to multitask and adapt to frequent shifts in priorities with a sense of urgency.

The use of external recruiters/staffing agencies requires prior approval from our Human Resources Department. The Human Resources Department at Imperative Care requests that external recruiters/staffing agencies not to contact Imperative Care employees directly in an attempt to present candidates. Complying with this request will be a factor in determining future professional relationships with Imperative Care.

Imperative Care will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external recruiter/staffing agency does not create any implied obligation on the part of Imperative Care.