Sr. Regulatory Affairs Specialist

04 Aug, 2022

Jobs

Sr. Regulatory Affairs Specialist

SeaSpine
Carlsbad, CA

Job Details

Description

SeaSpine is uniquely transforming Spinal Surgery with safe, fast, real-time solutions that give surgeons and hospital partners the confidence to deliver better outcomes to improve patient lives—NOW. If you are interested in being a part of our amazing journey as part of the HR Team. Please read on!

The position is a key member of the SeaSpine Regulatory Affairs department, providing senior specialist level support to the SeaSpine spine hardware business. The position represents Regulatory Affairs on product development design teams and is responsible for executing regulatory strategy, authorship, and submission of regulatory filings, as well as providing support on labeling requirements and developing and/or updating procedures as required.

Your key responsibilities: 

  • Provide regulatory guidance to quality systems, manufacturing, marketing, and product development groups.
  • Represent regulatory on project planning and design control meetings.
  • Provide guidance and interpretation of regulatory issues for product development teams, assuring that design and development requirements are met.
  • Provide regulatory guidance to design team for device labeling, promotional materials, and sales training 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.
  • Support compilation and maintenance of design dossiers and technical flies.
  • Work with other RA team members in support of international registrations, renewals, and tenders.
  • Review and approve 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 marked 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.
  • Maintain current knowledge of new regulations, policies, guidance documents, etc. issued by relevant regulatory authorities that may impact the company.
  • Develop and/or update processes and procedures as required to streamline practices or meet applicable regulatory requirements.
  • Support compliance with the Unique Device Identification program.
  • Perform other duties as assigned.

Who you are:

  • Bachelor’s Degree in a scientific or engineering field or equivalent combination of experience
  • A minimum of 4 years working in the medical device industry in Regulatory Affairs
  • Must have proven ability to prepare and submit documents to FDA, 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
  • 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
  • Demonstrates initiative and the ability to manage projects from start to completion
  • Familiarity with the FDA UDI Rule and/or GS1 system and data standards is beneficial
  • Experience with Blood, Human, Cell and Tissue based product experience highly desired

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c).

Learn more here

Job posted: 2022-08-04