Senior Manager Regulatory Affairs Mid-Size Markets (MSM) - Benelux, Portugal, Switzerland, Israel, Nordics or Greece

Description: About the Johnson & Johnson

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

Johnson & Johnson is a company committed to doing good for the world. We blend Heart, Science and Ingenuity to profoundly change the trajectory of health for humanity.

The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

About The Johnson & Johnson Med Tech

The Johnson & Johnson MedTech Companies’ purpose is to reach more patients and restore more lives. Having sophisticated patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopedics, cardiovascular and specialty solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

Our goal is to be among the best in the world, and we challenge ourselves each day to deliver innovative solutions that enable healthy outcomes for patients and Consumers. With our agility and responsiveness, we deliver differentiated experience for regional teams building competitive advantage for J&J Consumer Health. Our commitment is to put our many and diverse customers at the center of everything we do. We build agile, scalable and innovative business intelligence solutions in partnership with IT, Marketing & Commercial teams which help the Squads with all the Insights and information required to be ahead of the market.

Senior Manager, Regulatory Affairs Mid-Size Market (MSM)

The Senior Manager, Regulatory Affairs Mid-Size Market (MSM) serves as the RA Leader for MSM region for all MedTech franchises and ensures regulatory compliance and access to market for JnJ medical devices via regulatory approvals and life-cycle maintenance. This Leader leads a team of cross-countries RA professionals and represents RA in MSM Leadership Team. This position can be in any of the MSM countries: Portugal, Greece, Nordics, Benelux, Israel, or Switzerland.

Objectives of the Position

• Ensures product compliance with appropriate laws and regulations in MSM region.
• Establishes processes and procedures for monitoring, impact assessments, and compliance strategies.
• Ensures that MSM requirements are communicated to Franchises and Regional leads.
• Leads all aspects of Regulatory Affairs operations within MSM region.
• Delivers on components of the Regulatory Affairs strategic plan.
• Reviews global regulatory strategies and identifies gaps that may impact implementation.
• Translates the RA portfolio strategy into executable plans.
• Ensures accurate planning and execution of regulatory submissions in the region, co-operating with central planning team.
• Establishes and leads RA processes to ensure timely approvals.
• Represents Regulatory Affairs in the MSM Region LT to understand strategic priorities for the region and implement the MSM RA strategy aligned with functional and business strategies.
• Serves as spokesperson for the functional area, providing regular functional updates, flagging regulatory risks, co-operating with commercial team leader and supporting functions to ensure uninterrupted supply of product.
• Provides leadership, personnel development, training, coaching, and mentoring to the team.
• Leads succession planning for critical positions, budgets, and resources, including skilled professionals. Collaborates with team and Human Resources to build relevant development plans for the team.
• Collaborates with EMEAC RA Leads to identify synergies, drive harmonization, share experience, resources, and standard processes.
  
  

Qualifications:

• Degree in Science or equivalent experience required.
• Minimum of 10 years’ experience in medical devices Regulatory Affairs (preferred)
• Solid understanding of Medical Device Regulations and requirements in the EU (required)
• People management experience (required)
• Proficiency in the English language (required)
  
  

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

What You Will Need To Succeed

We are looking for a dedicated and motivational leader with a passion for people development and teamwork. It is important that this leader can work independently to tackle regulatory and operational issues of moderately complexity. To be successful in this role you must demonstrate sound decision-making with available information, good problem-solving, the ability to influence at all levels of the organization.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Application

If you are interested in this position, please apply with an updated CV and Cover letter. The selection process will start during the 7-days posting period, please send in your application as soon as possible. We reserve the rights to close the advert earlier. All applicants can expect feedback on the application.

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