Johnson & Johnson companies are equal opportunity employers.
Manager, Regulatory Affairs - Center of Excellence (COE)-2463140815
Description
Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Manager, Regulatory Affairs - Center of Excellence (COE), to be located in Cincinnati, Ohio.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Manager, Regulatory Affairs (COE) will lead the Cincinnati-based team within the Global Surgery Regulatory Operations COE, supporting lifecycle management activities. This individual works closely with Supply Chain, Product Management, Labeling COE, as well as global RA affiliates and platform teams. He/she will provide oversight and management of Supply Chain and Compliance initiatives that impact the portfolio of marketed products (e.g., cost improvement and network optimization projects, newly regulated markets, changes in post-market registration requirements).
The Manager, Regulatory Affairs (COE) will drive operational efficiency by overseeing the preparation/submission of regulatory information required to sustain global market access, proactively identifying issues, effectively communicating timelines for project completion, and addressing complex issues that may impact registration status.
The Manager, Regulatory Affairs (COE) will be responsible for recruiting and managing RA Associates as well as external contractors, successfully balancing project priorities and RA resources across multiple product platforms. He/she will provide input on regulatory processes, systems, and metrics. This individual also aligns departmental goals with business strategy and effectively manages the departmental budget.
Qualifications
A minimum of a Bachelors Degree is required. A Bachelors Degree in a technical field is preferred. An Advanced Degree is preferred. A minimum of 8 years experience in a healthcare regulated industry required. Medical device industry experience is preferred. A minimum of 3 years experience conducting regulatory activities that achieved global regulatory approval of medical devices, consumer and/or pharmaceutical products is required. A RAC certification is preferred. Working knowledge and thorough understanding of how global regulations impact product registration is required. The ability to develop a cohesive staff with a “long term vision” is required. The ability to assist with the harmonization of an organization is required. Strong written & verbal communication and presentation skills are required. Prior success in a project management capacity is required. The ability to work collaboratively in a highly matrixed environment is required. The ability to build and sustain productive partnerships across multiple platforms is required. The ability to evaluate new regulatory requirements as well as regulatory changes, and correctly assess business impact is required. The ability to plan and execute complex projects through timely completion with positive business results is required. The ability to lead teams and delegate tasks effectively is required. Experience in managing virtual teams is preferred.
This role will be based in Cincinnati, Ohio and requires up to 15% travel, including international.
BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-Ohio-Cincinnati
Organization: Ethicon Inc. (6045)
Job Function: Regulatory Affairs
Travel:Yes, 10 % of the Time
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement
Manager, Regulatory Affairs - Center of Excellence (COE)-2463140815
Description
Ethicon, a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Manager, Regulatory Affairs - Center of Excellence (COE), to be located in Cincinnati, Ohio.
The Ethicon business offers a broad range of products, platforms and technologies-including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices-that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women's health conditions, hernias, cancer and obesity. The Ethicon business combines products and services of two market leading legacy companies, both with long histories of medical innovation. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and electiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
The Manager, Regulatory Affairs (COE) will lead the Cincinnati-based team within the Global Surgery Regulatory Operations COE, supporting lifecycle management activities. This individual works closely with Supply Chain, Product Management, Labeling COE, as well as global RA affiliates and platform teams. He/she will provide oversight and management of Supply Chain and Compliance initiatives that impact the portfolio of marketed products (e.g., cost improvement and network optimization projects, newly regulated markets, changes in post-market registration requirements).
The Manager, Regulatory Affairs (COE) will drive operational efficiency by overseeing the preparation/submission of regulatory information required to sustain global market access, proactively identifying issues, effectively communicating timelines for project completion, and addressing complex issues that may impact registration status.
The Manager, Regulatory Affairs (COE) will be responsible for recruiting and managing RA Associates as well as external contractors, successfully balancing project priorities and RA resources across multiple product platforms. He/she will provide input on regulatory processes, systems, and metrics. This individual also aligns departmental goals with business strategy and effectively manages the departmental budget.
Qualifications
A minimum of a Bachelors Degree is required. A Bachelors Degree in a technical field is preferred. An Advanced Degree is preferred. A minimum of 8 years experience in a healthcare regulated industry required. Medical device industry experience is preferred. A minimum of 3 years experience conducting regulatory activities that achieved global regulatory approval of medical devices, consumer and/or pharmaceutical products is required. A RAC certification is preferred. Working knowledge and thorough understanding of how global regulations impact product registration is required. The ability to develop a cohesive staff with a “long term vision” is required. The ability to assist with the harmonization of an organization is required. Strong written & verbal communication and presentation skills are required. Prior success in a project management capacity is required. The ability to work collaboratively in a highly matrixed environment is required. The ability to build and sustain productive partnerships across multiple platforms is required. The ability to evaluate new regulatory requirements as well as regulatory changes, and correctly assess business impact is required. The ability to plan and execute complex projects through timely completion with positive business results is required. The ability to lead teams and delegate tasks effectively is required. Experience in managing virtual teams is preferred.
This role will be based in Cincinnati, Ohio and requires up to 15% travel, including international.
BE VITAL in your career; Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
J2W:LI NA
Primary Location:North America-United States-Ohio-Cincinnati
Organization: Ethicon Inc. (6045)
Job Function: Regulatory Affairs
Travel:Yes, 10 % of the Time
Certain sites within the Johnson & Johnson Family of Companies participate in E-Verify as appropriate in accordance with Company guidelines and federal or state law. To learn more about the government sponsored program and to see a list of the sites that are currently enrolled, please click here.
Johnson and Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.
EEO is the Law
EEO is the Law GINA Supplement