FDA Regulatory Manager Or Senior Manager

Manatt, Phelps & Phillips, LLP New York , NY 10007

Posted 3 months ago

Manatt Health is seeking a highly qualified manager or senior manager with relevant expertise to work on medical device regulatory matters. This is an exciting opportunity to be part of a nationally recognized healthcare strategy consulting team and work with clients who are passionate about improving healthcare.

Ideal candidates will have a deep understanding of the U.S. Food and Drug Administration's (FDA's) medical device regulatory issues as well as demonstrated ability to successfully navigate the FDA's complex submission and review process, and experience guiding clients through the FDA approval process. Experience with FDA policies and requirements, product development and submissions processes, regulatory submissions such as 510(k) Notices, Investigational Device Exemptions (IDEs), De Novo Requests and Premarket Approval Applications (PMAs); FDA premarket review responses, FDA jurisdictional and postmarket compliance issues, advertising and promotion compliance, and clinical trial guidance is preferred. Candidates will be able to apply extensive regulatory expertise to determine the best approach to help clients achieve successful results, including identifying potential issues and regulatory risks.

Qualifications:

  • Master's degree from a leading institution in a relevant area of study, or an equivalent combination of education and work experience (scientific, health or biotech background preferred).

  • Two or more years of substantive regulatory experience, preferably in handling FDA medical device matters.

  • Demonstrated interest in and enthusiasm for healthcare regulatory issues and trends.

  • Stellar academic credentials and excellent writing, research and analytical skills.

  • Strong client-facing skills with demonstrated experience in developing and managing client relationships.

  • Excellent written and verbal communication skills in a variety of settings and media.

  • Ability to develop training/presentation materials on key changes/updates on regulations, procedures, and programs to key stakeholder audiences.

  • A self-starter, highly motivated, intellectually curious, with the ability to work independently as well as in collaboration with others in a fast-paced environment.

About Manatt Health:

Manatt Health integrates legal and consulting expertise to better serve the complex needs of clients across the healthcare system. Combining legal excellence, first-hand experience in shaping public policy, sophisticated strategy insight, and deep analytic capabilities, we provide uniquely valuable professional services to the full range of health industry players. Our diverse team of more than 160 attorneys and consultants from Manatt, Phelps & Phillips, LLP and its consulting subsidiary, Manatt Health Strategies, LLC, is passionate about helping our clients advance their business interests, fulfill their missions, and lead healthcare into the future. For more information, visit https://www.manatt.com/Health.

Join the Team:

All candidates must apply through our online application portal: https://www.manatt.com/careers. Required application materials include a cover letter, transcripts and writing sample (Two to three pages from your academic or work experience where you are the sole author).

EEO/AA Employer/Veterans/Disabled

Apply Now


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Audit Manager Regulatory Reform

Citigroup Inc.

Posted 1 week ago

VIEW JOBS 1/11/2020 12:00:00 AM 2020-04-10T00:00 Function background/context: Internal Audit is a global organization of over 1000 professionals covering Citi's global businesses and service to clients and customers in over 180 countries. Citi's Internal Audit division provides independent assessments of the company's governance, risk management and internal control environment for key stakeholders including the Board of Directors, senior management and Citi's numerous regulators globally. Internal Audit is a change agent within Citi aimed to enhance the control culture of Citigroup worldwide and thereby support senior management decision making around the globe. Job Purpose: This role directs the timely delivery of complex high quality, value added assurance and audit reports for a portfolio of business activities, which meet the requirements of the Boards of Citigroup and Citibank, their affiliates and of Citi's respective regulators, globally. The position is for a C14 Senior Audit Manager within the ICG – Regulatory Initiative and Cetralized Markets Functions, reporting to the C15 Director. The Senior Audit Manager will contribute to the scoping and execution of the overall audit process. The role is integral component of the audit delivery in response to Regulatory Reform initiatives, including Dodd Frank/Volcker and MiFID. The Financial Crisis has led to an unprecedented level of regulatory reform. Much of the legislation and subsequent rule making will have a significant impact on Citi's global businesses and frequently specifically mandates Internal Audit coverage. Key Responsibilities: * Develops and executes a robust Audit Plan, by reviewable entity, for assigned businesses in accordance with Internal Audit standards, relevant government statutes and regulations and Citigroup and Citibank policies. * Delivers on time high quality audit reports, Internal Audit and Regulatory issue validation and (where appropriate, branch examinations, as well as business monitoring and governance committee reporting. * Directs complex audit activities for a component of a product line, function, or legal entity at the regional or country level including a portion of the audit annual plan. * Applies comprehensive expertise in one or more of the corporation's businesses and leverages this knowledge into a leadership role in one or more teams. * Proactively advances integrated auditing concepts and use of technology. Closely follows latest trends in own field and adapts them for application within own job and the business * Manages a complex and critical unit within Internal Audit, including a medium sized team of Internal Audit professionals. Recruits staff, develops talent, builds effective teams, and manages a budget. Possesses a broad and comprehensive understanding of different Internal Audit standards, policies and local regulations; applies a broad and comprehensive knowledge of high risk areas including: Consumer or Investment Banking, technology management; project/program management; regulatory compliance or supplier management. * Leads the professional development of Internal Audit staff. * Develops effective senior line management relationships and has a strong understanding of the businesses. * Applies an in-depth understanding of the inter-relationships of business and support units throughout the corporation and how they impact the overall control environment and the audit approach. * Uses excellent communication skills in order to influence a wide range of internal audiences including respective product, function, or regional executive management partners. May negotiate internally often at higher levels on matters which will have a major impact on the area managed. * Demonstrates strong judgment, political astuteness, and sensitivity to cultural diversity. * Possesses strong project management and interpersonal skills, makes sound decisions, exhibiting initiative and intuitive thinking. Consulted often by others for advice and opinions and recognized as a leadership role model. * Participates in major business initiatives and pro-actively advises and assists the business on change initiatives. * Frequently involved in matters that require complex judgments and solutions based on sophisticated analytical thought such as identifying solutions for a variety of complex and novel audit control issues. Analyzes reporting findings; Recommends appropriate interventions where needed. Proposes creative and pragmatic solutions for risk and control problems. Partners with Directors and Managing Directors to develop approaches for addressing broader corporate emerging issues. * Serves as lead reviewer for all types of reviews, including the most complex. * Reviews and approves Business Monitoring Quarterly Summaries. Qualifications and Competencies: * BA/BS or equivalent. Related certifications (CPA, ACA, CFA, CIA, CISA or similar) are a plus. * Senior level experience in a related role with experience in business, functional and people management, with proven abilities in taking responsibility for executing concurrently on a portfolio of high quality deliverables to stakeholders according to strict timetables. * Specific subject matter expertise regarding technology application control disciplines and a solid business understanding of products associated with the ICG Markets business. * Possesses working knowledge of Regulatory Reform, including Dodd Frank regulations and industry requirements. * Demonstrates experience in managing teams and managing integrated internal audit and assurance delivery within a matrix reporting environment. * Effective negotiation skills, a proactive and 'no surprises' approach in communicating issues and strength in sustaining independent views. This individual must be an articulate and effective communicator, both orally and in writing, with an energetic, charismatic and approachable style. * Strong interpersonal skills for interfacing with all levels of internal and external audit and management. Exceptional candidates who do not meet these criteria may be considered for the role provided they have the necessary skills and experience. Valuing Diversity: Demonstrates an appreciation of a diverse workforce. Appreciates differences in style or perspective and uses differences to add value to decisions or actions and organisational success. * ------------------------------------------------ Grade :All Job Level - All Job FunctionsAll Job Level - All Job Functions - US * ----------------------------------------------------- Time Type :Full time * ----------------------------------------------------- Citi is an equal opportunity and affirmative action employer. Minority/Female/Veteran/Individuals with Disabilities/Sexual Orientation/Gender Identity. Citigroup Inc. and its subsidiaries ("Citi") invite all qualified interested applicants to apply for career opportunities. If you are a person with a disability and need a reasonable accommodation to use our search tools and/or apply for a career opportunity CLICK HERE. To view the "EEO is the Law" poster CLICK HERE. To view the EEO is the Law Supplement CLICK HERE. To view the EEO Policy Statement CLICK HERE. To view the Pay Transparency Posting CLICK HERE. Citigroup Inc. New York NY

FDA Regulatory Manager Or Senior Manager

Manatt, Phelps & Phillips, LLP