ASSOCIATE DIRECTOR, REGULATORY AFFAIRS (CERENOVUS) - MEDICAL DEVICE BUSINESS SERVICES, INC.

CERENOVUS, a division of Johnson & Johnson MedTech, is recruiting for an Associate Director, Regulatory Affairs.
This role will work a Flex/Hybrid schedule and must reside within a commutable distance of Irvine, CA.
About Johnson & Johnson At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal.
Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.
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The Associate Director, Regulatory Affairs translates regulatory strategies into executable plans for the Cerenovus Regulatory team and administers day-to-day Regulatory Affairs operations by managing teams of employees or contractors.
Primary Responsibilities.
· Directs and coordinates activities concerned with the submission and approval of products to government regulatory agencies to ensure rapid and timely approval of new or modified devices and continued regulatory support of marketed devices.
· Manages and reviews the preparation of U.
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and E.
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regulatory submissions, including, but not limited to 510(k)’s, IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of neurovascular Class I, II and III devices.
· Provide guidance and interpretation of global regulatory requirements to help ensure efficient use of resources and oversees responses to regulatory questions and correspondence.
· Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
· Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new drugs and regulatory support of marketed drugs and other products.
· Consults with management personnel to establish and prepare appropriate regulatory strategies.
· Communicate with Regulatory Agencies regarding strategies and submissions and to resolve matters and expedite the approval process.
· Partner with cross functional teams by providing independent regulatory guidance and support to life cycle management teams for strategic planning, design and development, and post-market surveillance and compliance activities.
· Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
· Responsible for communicating business related issues or opportunities to next management level.
· For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
· Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
The base pay range for this position is $ to $ based on experience.
The Company maintains highly competitive, performance-based compensation programs.
Under current guidelines, this position is eligible for an annual performance bonus.
The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year.
Bonuses are awarded at the Company’s discretion on an individual basis.
Qualifications Required Qualifications.
· Minimum of a Bachelor’s Degree is required, Advanced Degree strongly preferred.
Preferred fields of study include Biological or Physical Sciences.
· Minimum 8+ years relevant Regulatory Affairs experience within the Medical Device and/or Pharma Industry required; 6+ years’ experience with Master’s Degree, 4+ years’ experience with PhD.
· Experience working in the Medical Device Regulatory environment preparing submissions for Class II and III Medical Devices is required.
· At least 3+ years of people leadership experience is required.
Supervision on Contractors can count towards this requirement but may not satisfy all of it.
· Direct experience interacting with Regulatory Authorities in both the US & EU strongly preferred.
· Ability to partner and influence key stakeholders is required.
· Excellent written, verbal communication and presentation skills.
· Tactical and strategic regulatory and business knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class III devices (US and EU).
· Ability to partner and influence key stakeholders on NPD and Lifecycle teams.
· Leverages scientific and technical understanding of medical devices to serve as a resource and strategic partner for development and planning throughout the product lifecycle in applicable markets.
· Builds, sustains, and rewards a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments.
· Advises and challenges others, including cross functional business partners, to ensure the best business-level best decisions are consistently made within the organization and based on the Credo.
· Guides internal clients in the application of standards and obtains clarification from regulatory agencies when needed.
· Connect by cultivating external relationships with regulators in key markets (in partnership with Regions, Policy and EU Strategy leads) and internally collaborating with the R&D, Med Affairs, Clinical Affairs, GSM and other partners.
· Shape by anticipating regulatory changes in key markets to maximize patient access to innovative technologies.
· Lead by acquiring and developing a diverse team of talented regulatory professionals and transparently communicating in a constructive manner.
· Deliver by mobilizing and inspiring an accountable team to deliver results for on-time clearances/approvals with a global and enterprise-wide mind-set and balance with strategic and short-term goals.
· Expected domestic and international travel % Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.
areers.
nj.
om.
This job posting is anticipated to close on .
The Company may however extend this time-period, in which case the posting will remain available on https://www.
areers.
nj.
om to accept additional applications.