Principal Regulatory Affairs Specialist

Orthofix-posted 1 day ago

Full-time • Mid Level

1,001-5,000 employees

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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.

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 flies.
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.
Participates 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.

Bachelor’s Degree
A Minimum of 4 years working in the medical device industry
2-4 years' experience in RA required
Must have 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); must have 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

Bachelor’s Degree in a scientific or engineering field or equivalent combination of experience
Experience with FDA 510(k) submissions for orthopedic devices preferred but not required
Experience with EU MDR highly desired.
Experience with Blood, Human, Cell and Tissue based product experience highly desired

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