Principal Regulatory Affairs Specialist

Orthofix

About The Position

Why Orthofix? Guided by our organizational values – Take Ownership | Innovate Boldly | Win Together – we collaborate closely with world-class surgeons and other partners to improve people’s quality of life. At Orthofix, we want team members who build relationships and share knowledge, challenge the status quo, and deliver results every day to help us achieve our vision to be the unrivaled partner in Med Tech. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them. Looking to change people’s lives? Look no further. How you'll make a difference? The position is a key member of the SeaSpine Regulatory Affairs department, providing highly experienced and independent support. The position represents Regulatory Affairs on product development design teams and is responsible for developing and executing regulatory strategy, authorship and submission of complex or numerous regulatory filings (including U.S. 510(k) and international filings), defining labeling requirements, developing and/or updating procedures as required, and may participate in other projects as needed. This position requires minimal oversight, and the Principal is able to prioritize multiple competing projects.

Requirements

Bachelor’s Degree in a scientific or engineering field or equivalent combination of experience
A Minimum of 7 years relevant Regulatory Affairs experience within medical device industry
Must have proven ability to prepare and submit premarket submissions, such as Premarket Notifications (510(k)s), investigational Device Exemptions (IDEs), and Premarket Approval Applications (PMAs) for Orthopedic devices
Must have proven successful CE marking under EU MDR of devices through design dossier or technical file process
Strong knowledge of US and international medical device regulations.
Ability to interpret requirements and provide guidance to cross functional team members.
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
Focuses on results, takes initiative without direction, takes ownership for all work within scope.

Nice To Haves

Experience with Blood, Human, Cell and Tissue based product experience highly desired

Responsibilities

Provide regulatory guidance to quality systems, manufacturing, marketing and product development groups.
Represent regulatory department 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 including but not limited to device labeling, and promotional materials.
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 EU MDD/MDR design dossiers and technical flies.
Coordinate or work with other RA and cross functional team members in support of registrations, renewals and tenders.
Review and approve all engineering and document change orders.
Represent RA department in external audits, as well as Internal audits as required.
Participates in all respective agency audits and responses to support audit findings or other respective actions related to such audits.
Directly interact with regulatory bodies in US and/or international regions in a respectful and professional manner and ensure issued identified are addressed in a timely manner.
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, 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 team members.
Identify company gaps with new or existing regulations, and initiate changes to address these.
Perform other duties as assigned.