Executive Director leading firm - wide Compliance Risk Assessment program for SMBC Group in financial services. Managing CRA process and collaborating with regulatory stakeholders.
About the role
- Regulatory Affairs Specialist II providing regulatory guidance to project teams in Orthopaedics at Johnson & Johnson. Responsible for developing and executing regulatory strategy for product approvals.
Responsibilities
- 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.
- Provides key deliverables in a timely manner and in accordance with project team expectations and regulatory project plan timelines (e.g., regulatory strategy, regulatory change assessment, etc.)
- Researches and collects data; and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates.
- Advises on regulatory labeling requirements specifications for modified products, and reviews product labeling to ensure compliance.
- Conduct regulatory promotional labeling and marketing compliance reviews ensuring activities and communications are consistent with product labeling, are adequately supported and are following applicable laws, regulations and policies related to advertising & promotion of regulated products.
- Represents Regulatory Affairs on cross-functional project teams and provides regulatory guidance.
- Provides solutions to a variety of problems of moderate scope and complexity.
- Provide 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.
- Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
Benefits
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Senior Product Environmental Compliance Specialist leading compliance initiatives in Stryker's Endoscopy division. Driving regulatory strategy and cross‑functional alignment in a hybrid role.
Payments RCA Professional at U.S. Bank focused on operational loss reporting and risk management compliance. Collaborating across teams to ensure timely and accurate reporting and process improvement.
Compliance Representative managing risk and compliance under U.S. Bank's financial services. Involves collaboration across various teams and addressing policy violations and customer complaints.
Corporate Compliance Analyst supporting the development of a global compliance program at Vantage Data Centers. Engaging in risk assessments, training, and compliance monitoring to drive process improvements.
Senior Executive/Executive in charge of compensation and compliance at Orfium, ensuring legal adherence and proper employee relations while managing benefits and compensation strategies.
Compliance Reporting Assistant supporting compliance activities and gaining hands - on experience in a dynamic international environment. Assist in preparing reports and dashboards while collaborating with various stakeholders.
Environmental Compliance Specialist managing compliance with environmental laws for natural gas projects in multi - state areas. Supervising consultants, preparing compliance reports, and conducting audits.
Compliance Analyst ensuring adherence to Federal Energy Regulatory Commission and ERCOT standards. Collaborating with various teams to manage compliance documentation and processes.
Manage compliance testing for Manulife within the Canada Segment team. Analyze key business controls and recommend improvements for compliance in financial institutions.