Quality & Regulatory Affairs Consultant
- Assist consulting team and clients with the preparation and submission of medical device registration/licensing applications to a single or specific number of regulatory markets.
- Prepare renewals or amendments to the above, and act as support to a project team lead (project manager or consultant); this may include direct client interaction which should be well documented.
- Develop and leverage knowledge of requirements and expectations for medical device submissions, understand the registration process, including whether tasks should be completed in parallel or sequentially and clearly delineate each process/phase to clients.
- Assist with client documentation review, gap analysis, provide input regarding the acceptability of existing data, and explain how to satisfy the submission requirements.
- Assist with or redirect internal or external inquiries related to quoting project hours and scope, including potential grouping or classification as applicable.
- Escalate complex regulatory issues identified by team or clients to senior experts as appropriate and follow through to resolution.
- Prepare regulatory reports.
- Perform activities such as: - Research on regulatory issues, involving web searches, review of internal library and other means - Summarizing technical and regulatory information in a written form - Serve as Lead Consultant on multi-market research projects as needed - Handle client inquiries and provide consultation regarding medical device quality assurance and regulatory compliance issues, such as: - Drafting / reviewing mandatory or operating procedures needed for quality assurance or regulatory compliance - Reviewing product labeling - Responses to issues arising from registrar or regulatory inspections / audits.
- Act as regulatory support on larger consulting project teams comprised of multiple stakeholders, including senior consultants, business development and project management.
- Where appropriate, act as initial liaison with local regulatory authorities on behalf of clients.
- Support Consulting team with RA and QA priorities as needed. Read and follow the Underwriters Laboratories Code of Conduct and follow all physical and digital security practices.
- Bachelors' degree, preferably in a Medical, Engineering or Science field.
- Advanced, professional-level written and verbal English and excellent communication skills.
- Generally, 2-5 years of Quality Assurance and/or Regulatory Affairs experience working in the medical device field, in a regulatory, submissions or quality support role.
- Consulting experience a plus.
- Excellent attention to detail, research or device registrations experience a plus..
- Proficiency with Microsoft Office software.
- Strong multitasking, organization and prioritization skills.