Senior Director RA, EMEACanada EPNV

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Job Sub Function:

Job Category:

All Job Posting Locations:

Job Description:

Johnson & Johnson MedTech is recruiting a Senior Director RA EMEA/Canada EP/NV to be based in Ireland Switzerland or Israel supporting the Electrophysiology (EP) and Neurovascular (NV) businesses.

The Senior Director RA EMEA/Canada EP/NV serves as the regulatory leader for the region overseeing all aspects of regulatory activities in these markets. This role actively contributes to the development and execution of regulatory strategies engages closely with senior business leaders and exercises significant independent judgment to drive business outcomes.

Key Responsibilities:

Responsible for leading the regional Regulatory Affairs teams across EMEA and Canada to support and enhance business growth and accelerate product approvals by providing strategic leadership ensuring effective prioritisation and governance building capability and driving the delivery of strategic and operational plans including submissions approvals lifecycle management and market access maintenance.

Represents the regional RA organisation in global and regional leadership discussions contributing market insights shaping governance discussions and driving implementation of agreed strategic and operational priorities.

Lead regional regulatory strategy development ensuring regional country and cultural dynamics are reflected in strategic and operational plans that advance global Business Unit priorities market needs and business objectives.

Ensure ongoing product compliance by monitoring regulatory change assessing business and market impact and directing appropriate regional actions.

Create a diverse vibrant and capable regional regulatory workforce by promoting the importance of recognising and embracing cultural differences strengthening strategic capability and execution discipline and building a sustainable talent pipeline through active recruitment retention and development strategies.

Represents Business and J&J MedTech strategies in external regulatory forums global & regional trade associations and in regulatory authority meetings.

Drive regulatory operating model excellence by advancing scalable processes digital capabilities and data-driven transparency to improve efficiency and enable strategic decision making.

Other Duties:

Responsible for regional RA budget planning and control ensuring regulatory activities are delivered within timeline and budget and determining and communicating the financial implications of regulatory activities on business results. Ensures that company policies procedures and practices follow global policies and regional requirements. Provides advice analysis and guidance to senior leadership on critical cross functional project. Perform ad-hoc tasks assigned by Regional and Global Boards as appropriate.

Qualifications & Experience:

Required Minimum Education: Bachelors degree. Preferred advanced degrees and education in medicine engineering science or law highly preferred. Other: MBA or advanced degree preferred

Required Years of Related Experience: A minimum of 15 years of experience in a regulated industry with a minimum of 3 years experience in management positions including managing people.

Required Knowledge Skills and Abilities:

Senior leadership experience is required especially interacting with senior leaders and influencing strategy and decision making at senior levels
Demonstrated track record of formulating regional regulatory strategies that align with business deliverables is required

Medical Device experience preferred but not required. Global franchise / business unit RA experience supporting an OUS market with diversity of experience i.e. sector company function product

Regulatory compliance risk evaluation and balanced decision making

Experience leading diverse teams in a matrix environment cultural awareness Talent Mgmt in competitive markets

Large budget cost center management and business planning in a complex financial model

Regional or multi market experience with Regulatory Affairs including Emerging markets.
Experiences and leadership in working with external industry groups and International organizations is a plus; Outreach influencing negotiation shaping collaboration with Health authorities or industry trade groups
Strong English language (spoken and written) capability; other languages of regional countries are welcomed
Live the credo in a way that creates a trusting collaboratively and ethical work environment

Prior hands-on Cardiovascular submission experience with a track record of obtaining approvals across multiple regions (US Europe UK APAC).

Travel on the Job: Yes

Percentage Traveled: 25%

Required Skills:

Preferred Skills: