Assistant General Counsel - Regulatory Compliance Counsel Jobs in New_York - 169209 | Submit Resume | General Counsel Consulting
General Counsel Consulting
About us Attorney resources Employer resources Job listings Submit resume Contact Us
General Counsel Consulting
Sign In
Forgot your password?
New User?
General Counsel
service in helping
my organization
recruit for a hard
to fill position.
They did extensive
work on the front
end to understand
our needs and
our culture and
began referring
highly qualified
candidates almost
Melinda Burrows
Deputy General Counsel
- Litigation and
Compliance, Progress
Energy Service Company

Jobs for Law Students
Law Student - Law Firm in San Jose, CA
USA-CA-San Jose
File Clerk The candidate will be organizing and filing documents for client files. Creating compute.... [more]

Law Student - In-House in San Mateo, CA
USA-CA-San Mateo
Winter Intern ? Tax Services The candidate will serve as members of client service teams. Interns a.... [more]

Law Student - In-House in Chicago, IL
Intern - Tax Services The intern will be exposed to a wide variety of projects and industries. Will.... [more]

Articles By
Harrison Barnes From
BCG Attorney Search


Click here

Job of the Day
Associate General Counsel, Corporate Governance
Newark Delaware United States

What You'll Contribute The Associate General Counsel and Assistant Secretary will be a member of the Corporate Secretary team within the Legal, Government Affairs, and Corporate Communication organization, reporting to the Corporate Secretary and ...

In House Legal Job Listings

Assistant General Counsel - Regulatory Compliance
Refer job# WUTP169209
Assistant General Counsel - Regulatory Compliance The candidate will be advising, counseling, and actively participating in the development of procedures, practices, and systems that ensure compliance with regulatory standards, with particular emphasis on the US FDA's quality system, medical device reporting, and corrections and removals regulations, the new European IVD regulation (IVDR), and international medical device standards, including ISO 13485 and ISO 14971. Providing counsel and advice to the company globally on regulatory and/or legal-regulatory issues with particular emphasis on FDA and other international regulatory authorities. Assisting in managing and responding to regulatory agency investigations and/or administrative actions. Actively participating as a standing member of the operating companies regulatory decision-making (e.g., field action and premarket notification) committees. Coordinating efforts across the operating companies and various business units to present a unified message to various regulatory bodies as well as quasi-regulatory non-governmental organizations (e.g., the WHO). Monitoring and tracking proposed healthcare-related regulations that will impact the company's businesses. Developing and presenting plans to the appropriate governing bodies that result in modifications to existing or proposed regulations that allow for the operating companies to offer their complete array of products and services. Providing regulatory reviews and analyses of new business ventures or acquisitions.

The candidate should have a law degree from an accredited law school with a strong academic record. Licensed to practice law in at least one jurisdiction in the United States. Should have 10+ years as a medical device/drug attorney with a significant focus on quality systems, adverse event/vigilance reporting, and field actions / recalls. Strong knowledge of FDA and international medical device and in vitro diagnostics requirements, and submission/reporting processes. Solid working knowledge of legislative and regulatory processes with strong established relationships or contacts with relevant regulatory authorities. Demonstrated ability to lead an organization to appropriate decision-making. Leadership capability and commitment to excellence. Experience in medical device and in-vitro diagnostics quality, regulatory, clinical, and compliance matters is preferred. Law firm and/or in-house experience in a biotech, pharmaceutical, or medical device company is preferred. Team player and excellent legal analysis and communication skills. Effective, concise, and articulate written and verbal skills. Extremely responsive and client-service oriented. Unquestionable integrity and drive to do the right thing. Committed to diversity and inclusion. Superior work ethic and positive attitude. Strong understanding of regulatory compliance and quality management systems. Ability to navigate complex regulatory issues and identify creative and compliant solutions. Ability to educate and work closely with other in-house attorneys focused on other areas of law (IP, M&A, Litigation, Competition, Commercial) where the client needs intersect. Ability to explain complex regulatory compliance concepts in everyday business language. Basic understanding of commercial law and grounding in key business processes (accounting, finance, operations, marketing). Experience with other regulatory matters (e.g., EPA, USDA, REACH).
This particular job is currently not active. However, since our clients regularly share with us similar and other job openings, we strongly recommend that you submit your resume. We shall review your resume and get in touch with you as soon as a suitable vacancy comes up to further discuss your interest in exploring the opportunity. Assisting you is our highest priority.

Please be assured that none of your materials will be forwarded to any employer without your consent. Of course, all inquiries are kept strictly confidential.

Shoot for the moon. Even if you miss it, you will land among the stars.