Location: Raritan, NJ
Company: Johnson And Johnson
has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives.
Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit . The RA Manager, Global Regulatory Affairs, Biosurgery is
responsible for partnering cross-functionally with team members/leaders to develop and implement global regulatory strategies to drive pipeline development and lifecycle management activities for biologic-led and device-led combination products.
This position may also include managing RA team members in the development and execution of regulatory strategies to obtain market access for new/modified platform products. The individual is responsible for lifecycle management activities required to maintain existing products in the market such as filing change supplements and annual reports in the US and EU, as well as supporting post-approval safety reports and clinical trial submissions.
The RA Manager is also responsible for supporting international registrations by partnering with local affiliates in non-US and EU markets.
The RA Manager will be a strategic business partner, evaluating new and changing regulatory requirements and determining the most effective and efficient strategies for obtaining product clearances/approvals/registrations in key countries. Key Responsibilities : • Prepare, review, and implement new product development/new product introduction/lifecycle management regulatory strategies and plans to ensure continued access of combination products globally. • Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for product clearances and approvals.
• Partner with Quality organization to track and review internal and external partner changes made to existing products and to determine global regulatory impact. • Plan and coordinate Global regulatory submissions with internal and external partners. • Plan and coordinate regulatory submissions with international Regulatory Affairs affiliates; review and compile submissions after final documents are received. • Lead and implement process and technical regulatory improvements for the Global Regulatory Affairs organization.
• Review and provide feedback on SOPs, including, but not limited to internal company procedures related to regulatory, clinical, & pharmacovigilance activities, regulatory support during audits/inspections, and educational materials. • Partner with the internal Global Strategy & Implementation and Regulatory Policy organizations to monitor the global regulatory environment and to communicate backssments of the impact of new and changing regulations on the products under the scope of responsibility. • Educate associates on regulatory policies and practices. • Provide guidance to business leadership to optimize strategies across functional areas.
• Exercise highly complex level of independent judgment and execution directly impacting the operational results of the business unit; manages, oversees and balances resource allocation across critical projects. • Establish and ensure deployment of learning initiatives and training for cross-functional partners on current and emerging regulatory and related requirements. • Ensure that company policies, procedures, and practices comply with appropriate regulatory requirements. • Provide key input for product claims and evidence support, and review and approve Advertising and Promotional materials in accordance with local regulations, as requested.
The base pay range for this position is $115,000 to $175,000 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.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market. Experience and Skills : • Minimum of a Bachelor's level degree within a technical related discipline is required. Advanced Degree strongly preferred. • Minimum 6 years relevant regulated industry (Med Tech/Pharma/Consumer) experience required. Previous experience with medical devices highly desired. • Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables.
• Previous experience with drug/biologic or combination product regulations strongly preferred. • Experience working with professional and trade associations a plus. • Prior experience with regulatory support for device and drug/biologic clinical trial documentation (e. g. Investigator's Brochures, Development Safety Update Reports, etc. ) highly desired. • Business proficient in spoken and written English language. • Some international travel may be required for this role (10%).
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, interaction, interactionual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Management & Executive Jobs refer to positions at the higher levels of an organization's hierarchy, involving significant responsibility over strategic planning, decision-making, and leadership. Executives set visions, goals, policies, and they often participate in high-level negotiations. Managers oversee the implementation of these directives, leading teams, managing resources, and ensuring operational efficiency. These roles demand strong leadership, communication, and analytical skills, as well as extensive experience in their respective fields. Typical titles include CEOs, CFOs, directors, and various department heads, each with a critical influence on the company's success and direction.
Management & Executive Jobs refer to positions within an organization that involve overseeing operations, making strategic decisions, and leading teams or entire companies towards their objectives. These roles typically require a mix of leadership skills, industry experience, and strategic thinking. Executives and managers are often responsible for setting goals, organizing resources, managing personnel, and ensuring that their department or organization meets performance targets. Distinctive characteristics of these jobs include high responsibility, decision-making authority, and frequently, a corresponding higher level of compensation reflecting their critical role in an organization's success.
Management & Executive Jobs refer to positions at the higher levels of an organization's hierarchy, involving significant responsibility over strategic planning, decision-making, and leadership. Executives set visions, goals, policies, and they often participate in high-level negotiations. Managers oversee the implementation of these directives, leading teams, managing resources, and ensuring operational efficiency. These roles demand strong leadership, communication, and analytical skills, as well as extensive experience in their respective fields. Typical titles include CEOs, CFOs, directors, and various department heads, each with a critical influence on the company's success and direction.
open development space. You are self-motivated and capable of working both independently and with cross functional teams to guide manufacturers and their products through the process. Your strong technical knowledge, Project Management and communication skills will be used daily in this role.
Evaluate device entries and independently manage approvals Work with cross functional teams on device issues Manage requirement and process changes while communicating them to OEMs that are in process. Educate OEMs as needed Certify device updates PDN-9af3e95e-7b26-41de-bc92-c8d9d923d7cd
