Principal Regulatory Affairs Specialist
Orthofix
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Provide regulatory guidance to quality systems, manufacturing, marketing and product development groups
- Represent regulatory on project planning and design control meetings
- Define strategy and provide guidance and interpretation of regulatory issues for product development teams, assuring that design and development requirements are met
- Define strategy and provide regulatory guidance to design team for device labeling, promotional materials, and sales training material
- Independently prepare and submit 510(k)s and other regulatory filings for new products or changes to existing products, including management of interactions with regulatory authorities and ensuring that all activities are accurately and timely documented with minimal oversight
- Ensure compilation and maintenance of design dossiers and technical files
- Coordinate or work with other RA team members in support of international registrations, renewals and tenders
- Review and approve all engineering and document change orders
- Support Quality Assurance during FDA Inspections, Notified Body, AATB and any other external audits, as well as Internal audits as required
- Participate in all respective agency audits and responses to support audit findings or other respective actions related to such audits
- Maintain current status of FDA submissions, CE Mark technical files, international submissions and approvals, and design project deliverables for regular management update
- Ensure regulatory compliance of manufacturing and operational processes, which includes review and approval of NCRs, MDRs, deviations, etc.
- Drive projects to maintain current knowledge of new regulations, policies, guidance documents, etc. issued by relevant regulatory authorities, which may impact the company
- Develop and/or update processes and procedures as required to streamline practices or meet applicable regulatory requirements
- Educate and train Regulatory team to develop personnel
- Identify company gaps with new or existing regulations, and initiate changes to address these
- Perform other duties as assigned
Requirements
- Bachelor’s Degree
- A Minimum of 4 years working in the medical device industry
- 2-4 years' experience in RA required
- Proven ability to prepare and submit documents to FDA in a timely manner, such as 510(k) Premarket Notifications, investigational Device Exemptions (IDEs), and Premarket Approval Applications, (PMAs)
- Proven successful CE marking of devices through design dossier or technical file process
- Effective written and verbal communication skills
- Ability to interface effectively with individuals from a wide variety of disciplines during the course of projects and to build coalitions
- Ability to train others
- Ability to prepare and execute regulatory presentations to others
- Successfully sets priorities, performs tasks in an orderly fashion and meets deadlines for multiple competing projects
- Demonstrates initiative and ability to manage complex and multiple competing projects from start to completion
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
510(k) submissionsregulatory filingsdesign dossierstechnical filesNCRsMDRsinvestigational Device Exemptions (IDEs)Premarket Approval Applications (PMAs)CE markingregulatory compliance
Soft skills
effective communicationteam collaborationtrainingproject managementinitiativeprioritizationorganizational skillspresentation skillsproblem-solvingadaptability
Certifications
Bachelor’s Degree