The Director for Ethicon's Biosurgery and Wound Closure & Healing Platform will lead a team of RA professionals and be accountable for partnering with R&D and Global Strategic Marketing platform leaders as well as other cross-functional team members/leaders to develop and implement global regulatory strategies to drive pipeline development and global launch excellence. Primary products supported are considered significant-risk medical devices or biologics worldwide (e.g., Class II and Class III devices and BLA products in the US). This role can also support combination product strategy (i.e., biologics/medical device, medical devices with a medicinal component) in some capacity. Primary responsibilities will include the development and execution of regulatory strategies to obtain market access for new/modified platform products. The individual is also accountable for lifecycle management activities required to maintain existing products globally. The Director, Regulatory Affairs, will evaluate the impact of current and emerging standards and regulations and figure out most effective and efficient strategies for acquiring or maintaining product clearances/approvals/registrations in key markets.

Key Responsibilities:

• Act as a strategic partner with colleagues in R&D, Preclinical Research, Clinical Development, Global Strategic Marketing, Supply Chain and Health Economics Market Access teams to develop and implement global regulatory strategies for new and existing products to support regulatory approval/clearance and post-marketing activities

• Demonstrates a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management.

• Leads RA staff members to support continued access of existing and modified/NPD products in key countries

• Applies strategic regulatory thinking along with technical expertise to implement regulatory strategies for product clearances and approvals

• Reviews various changes made to existing products to assess the impact on safety and effectiveness.

• Communicates existing policies and changes in the regulatory environment to management; and educates associates on regulatory policies and practices

• Interpret and communicate international and domestic regulatory guidance documents, policies, standards, and regulations for impact to the company

• Provides guidance to business leadership to help enhance the strategy across functional areas

• Influences and persuades to bring about process and technical improvements within the organization

• Influences regulations through networking and industry connections

• 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.

• Partners with EU, Regional, and Policy to monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations on the company's new product pipeline and help drive strategies to achieve a competitive advantage.

• Establish and ensure deployment of learning initiatives and training of cross functional partners on current and emerging regulatory and related requirements.

• Ensures that company policies, procedures and practices are in compliance with appropriate regulatory requirements.

• Identify and assess external innovation opportunities connected to the area of responsibility, especially those that will further accelerate access of new products in key countries.

• Responsible for communicating business related issues or opportunities to next management level

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

• 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

• Performs other duties assigned as needed

Qualifications

Required Qualifications:

• Minimum of a Bachelor's Degree is required, Advanced Degree strongly preferred.

• At least 12-15+ years of related experience in a Regulatory capacity.

• Previous experience with medical devices and/or biologics is required.

• Proven track record of developing and implementing global regulatory strategies that align with business results is required.

• Leadership, inclusive of being a people leader, experience is required.

Preferred:

• Experience working with professional trade associations and regulatory authorities is helpful.

• Demonstrated track record in collaborating with regulatory authorities, especially US FDA, to develop innovative regulatory strategies to market new or modified products is preferred.

• Experience in supporting or advising on complex projects, including internal and external innovations, that require clinical trials is preferred.

Other:

• Uses a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products

• Encourages and leads others to find ways to continuously improve, learn about new scientific, technological, and Regulatory developments, develop new capabilities, and learn from past challenges and experience in order to proactively adapt to change and drive innovative thinking.

• Evaluates the impact of current and emerging regulatory requirements on the business and organization in order to assist in defining the future vision and drive innovative thinking for Regulatory Affairs

• Integrates large amounts of changing, complex, and/or ambiguous information to make effective, complex decisions and clearly communicates complex issues to partners to achieve strategic and/or project goals

• Applies Regulatory knowledge of competitor products, strategies, and market segmentation to help see opportunities and potential Regulatory challenges.

• Integrates eye for business to decision making and development of regulatory strategies

• Guides others to effectively influence internal and external partners without direct authority and to anticipate and overcome obstacles and resistance

• Travel percentage - 20-30% national or international.

The anticipated base pay range for this position is $157,000 to $271,400. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. 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.

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company's long-term incentive program.

• Employees are eligible for the following time off benefits:

o Vacation - up to 120 hours per calendar year

o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

o Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

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.careers.jnj.com.