Job Description

The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.

The Johnson & Johnson Medical Devices Companies are recruiting for a ASPAC Regional Lead to be based at any of the Johnson and Johnson locations in the ASPAC Region, preferably in China or Singapore.

The ASPAC Regional Lead ensures the appropriate regulatory strategies are developed and executed in support of critical company initiatives managed by the Regulatory Operations Special Projects Team. This role is responsible for working with both their in-country team to ensure the needed regulatory actions are performed in order to maintain or introduce products in the marketplace. This role is also responsible for ensuring strong alignment of RA strategies between Special Projects and Base Business country RA Teams. Team works in support of all Business Units / Franchises across MedTech (except Vision).

This is a critical leadership position as the team supports the business in many key, complex markets such as China, Japan, South Korea, India and Taiwan - working with Project Teams, local RA and Supply Chain to minimize risk of disruption to product supply for these key markets.

Position duties & responsibilities:

• Lead the ASPAC Regional Special Projects Regulatory Team. Acts as the liaison between Regional Base Business and Regulatory Operations in the local country/region to align on strategies, identify interdependencies, anticipating risks, and mitigations to ensure market access for the products.
• Assure timely team completion of Country Impact Assessments to identify potential regulatory impact and are performed according to Local Regulations.
• Supervise the preparation and maintenance of local regulatory submissions and activities related to the submission and approval of products to government regulatory agencies in the designated countries of responsibility.
• Lead the discussions about team priorities to ensure higher priority country activities are completed first (restricted markets or high volume countries) before countries who have fewer restrictions.
• Ensures team maintains information related to changes in local regulations as well as status and planning of local regulatory actions utilizing MDRIM (Medical Device Regulatory Information Management - internal system)
• Partners with RA Special Projects Global PMO, Planning & Execution teams to ensure alignment on priorities across all programs and minimizing need to escalate issues to leadership.
• Work with local regional leaders and health authorities to shape local regulations, expedite approval of applications and to resolve issues.
• Translate Regional Strategies into local plans & tactics for the attraction of experienced professional talent for ASPAC.

Functional and Technical Competencies

• Build, sustain and motivate team of regulatory professionals in a region with historically high turnover rates; driving a culture that rewards collaboration and teamwork.
• Strong foundation of regulatory knowledge and expertise needed to educate and mentor others on developing regulatory strategies that meet business needs.
• Ability to utilize RA tools, such as MDRIM and the resulting dashboard data - to monitor team performance, analyze situations and leverage to problem solve.
• Strong written and verbal communication skills. Ability to use tools, such as PowerPoint, to clear depict scenarios, walk teams through brainstorm or problem solving sessions and effectively communicate clear messages to stakeholders/leaders.

Leadership Competencies:

• Strategic thinking and ability to partner and Influence key stakeholders at senior levels.
• Builds, sustains, and rewards a team culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments.
• Leverages expertise to educate and coach others on the development and execution of business plans and Regulatory Affairs strategies with a focus on innovative results.
• 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. Makes and stands behind complex and difficult decisions in ambiguous situations with a large potential impact on the organization.
• Connect by cultivating external relationships with regulators in key markets (in partnership with Regions, Policy and EU Strategy leads) and internally collaborating with key stakeholders and business partners.
• Shape by anticipating and influencing local health authorities on the strategy and approach for submission plans.
• Lead by acquiring and developing a diverse team of regulatory talent.
• Deliver by mobilizing an accountable team to deliver regional results with an enterprise mind-set and balance between long, strategic and short-term goals.

Qualifications

Education & Experience Requirements:

• Minimum of a Bachelor Degree within a technical related field is required. Masters Degree or above is a plus.
• Minimum 10 years relevant/regulated industry experience.
• Previous experience with Medical Device Regulatory Affairs in ASPAC is required.
• Team leadership experience is required.
• Experience working with multiple country regulations in ASPAC is required.
• Up to 25% Travel - mostly within region; occasionally 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.

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.jnj.com/.

At Johnson & Johnson, we\'re on a mission to change the trajectory of health for humanity. That starts by creating the world\'s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

Johnson & Johnson