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Manager Regulatory Affairs
Requisition ID: 7039171214
Cerenovus, a worldwide leader in the science on delivering innovative therapies for haemorrhagic and ischaemic stroke patients, a member of the Johnson & Johnson Family of Companies, and part of the Cardiovascular and Specialty Solutions (CSS) Franchise is recruiting for a Manager of Regulatory Affairs in Miami, FL is preferred but will consider a remote employee.
The purpose of this role is to administer the day-to-day Regulatory Affairs operations by directly or indirectly managing teams of employees or managing third-party vendors. In addition, this job exhibits a high degree of independent judgment and execute on plans that directly impact the operational results of business units.
POSITION DUTIES & RESPONSIBILITIES:
- Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies.
- Develop world-wide regulatory strategies to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
- Provides guidance to project team members regarding regulatory and compliance issues by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.
- Oversees the preparation and maintenance of regulatory submissions and files 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 products, including Class III devices.
- 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 devices and regulatory support of marketed devices.
- Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
- Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals.
- Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
- This role 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.
- Other duties as necessary/assigned.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
- Excellent written, verbal communication and presentation skills are required.
- 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) is required.
- The ability to partner and influence key stakeholders on NPD and Lifecycle teams is required.
- Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.
- The ability to cultivate 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 is required.
- The ability and experience to anticipate regulatory changes in key markets to maximize patient access to innovative technologies is highly desired.
- A minimum of a Bachelor’s Degree is required.
- A Master’s Degree is preferred.
- Minimum 8 years of related experience.
- Practical experience in a medical device Regulatory Environment, preparing submissions for Class II and III medical devices in the US and EU.
- This position is preferred to be located in Miami, FL and we will consider a remote employee and may require some travel.
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