Expert Compliance & Risk Consultant collaborating with engineering and operations for NERC compliance oversight. Supporting mitigation plans and developing internal controls within utility regulatory framework.
About the role
- Regulatory Affairs Specialist II providing regulatory guidance for Orthopaedics Velys power products at Johnson & Johnson. Focus on compliance and regulatory strategy execution.
Responsibilities
- Provides regulatory guidance to project teams in strategic planning and related submissions to support Orthopaedics Velys power products
- Develops and executes regulatory strategy for significant change supplements and 510(k) registrations
- Ensures compliance with regulatory agency regulations and interpretations
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines
- Prepares responses to regulatory agencies' questions and other correspondence
- Researches and collects data; and responds to requests from regulatory agencies and/or distributors
- Advises on regulatory labeling requirements specifications for modified products
- Represents Regulatory Affairs on cross-functional project teams and provides regulatory guidance
- Provides Regulatory Affairs support during internal and external audits
Requirements
- Minimum of a Bachelor’s Degree required ; Advanced Degree strongly preferred
- At least 2+ years of professional regulatory experience in a highly regulated industry required, preferably in medical device ( 1+ years with Advanced Degree )
- Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are required
- Experience in the preparation and submission of U.S. regulatory filings (e.g., 510(k), PMA) as well as European technical documentation reports files is strongly preferred
- Knowledge of U.S. and European regulatory processes is preferred
- Ability to work both independently and in a team environment to problem solve and recognize and find solutions for gaps in processes is desirable
Benefits
- Health insurance
- 401(k) matching
- Flexible work arrangements
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior management role overseeing technology compliance and risk management initiatives across wealth technology in India. Collaborating with stakeholders, and ensuring robust controls and compliance measures are in place.
International Regulatory Affairs Senior Specialist advancing global market access by providing technical support to ensure compliance for medical devices. Focused on facilitating registrations, renewals, and quality approvals.
Staff Quality Engineer leading quality compliance and process improvements at PROCEPT BioRobotics. Ensuring regulatory compliance and enhancing quality metrics in surgical robotics.
Analista de Compliance Júnior realizando análises de Due Diligence. Fortalecendo a ética e conformidade no ambiente corporativo.
Assistente de Compliance supporting integrity program activities like Due Diligence and investigations at compliance team. Ensuring adherence to internal policies and legal regulations.
Compliance Coordinator overseeing integrity program and corporate compliance at Renner. Leading audits, managing reports, and coordinating ethical culture initiatives.
Senior Analyst at Theo Müller Group developing SAP authorization concepts in various SAP systems. Involves implementation, auditing, and license management tasks within a collaborative environment.
Compliance Analyst ensuring adherence to internal policies and compliance regulations for Eldorado Institute. Engaging in integrity programs and handling internal investigations.
Responsible for ensuring compliance with French and international regulations at Liebherr - Aerospace Toulouse. Overseeing regulatory monitoring and authorizations related to export control.