Johnson & Johnson MedTech · 5 hours ago
Senior Regulatory Affairs Specialist (Spine) - MedTech Orthopaedics
Raynham, MA
Full-time
Onsite
Mid, Senior Level
$92K/yr - $148K/yr
5+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, aiming to improve health outcomes through advanced medical solutions. They are seeking a Senior Regulatory Affairs Specialist to support their Spine business, providing regulatory guidance and ensuring compliance with relevant regulations for product development and submissions.
Hospital & Health Care
Responsibilities
Provides regulatory guidance to product development teams in defining regulatory strategies, pre-marketing, and related submissions to support optimal timelines for new/modified product launches in the global market
Execute on the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to 510(k) submissions, Pre-Submissions, HDEs, Change Notifications, Technical Documents, and correspondence with Notified Bodies
Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams. This includes conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission
Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials
Defines data and information needed for regulatory approvals
Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
Provide Regulatory Affairs support during internal and external audits
Plans schedules for delivery of supporting documentations required for regulatory submissions on a project and monitors project through completion
Assists in the development of improved and efficient processes practices for Regulatory Affairs processes
Represents Regulatory Affairs on cross-functional project teams, guiding and supporting product development teams on both US and international issues, including Purchased for Resale products
Partners with other functions to define and generate data to assist with regulatory submissions
Review and provide regulatory authorization for various changes to product, procedures, etc
Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates
Qualification
Required
Minimum of a Bachelor's Degree required, Advanced Degree strongly preferred. Desired fields of study include science, engineering (e.g., biomedical, electrical, software, mechanical), business, legal, or similar
Minimum 5+ years of regulatory affairs experience in a highly regulated industry, preferably in medical device (3+ years with advanced degree)
Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are required
Must have excellent written, verbal communication, collaborative and strong attention to detail skills
High organizational skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks
Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion
Preferred
Experience in the preparation and submission of U.S. regulatory filings (e.g., 510(k), PMA) and/or European technical documentation reports files is strongly preferred
Knowledge of U.S. and European regulatory processes is preferred
Benefits
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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