Associate Director EU Regulatory Affairs Strategy-1805647195W
Based in the European HQ in Belgium, the Associate Director, Regulatory Affairs reports to the Director, Regulatory Affairs, Global & EU Strategy, and will lead a team of franchise RA strategy leaders. Exhibiting expertise in EU regulations regarding product design, development, manufacture and distribution, the Associate Director, Regulatory Affairs monitors and assess the impact of product specific regulations.
The Associate Director, Regulatory Affairs leads the strategy for CSS, including EU registrations and CE marking, registration of manufacturer or Authorized Representation for Franchise platforms.
DUTIES & RESPONSIBILITIES
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
* Leads and develops a team of RA professionals who accelerate EU registrations and CE marking including registration for multiple franchise platforms.
* Educates franchise Associates on EU requirements and integrating those requirements into franchise procedures.
* Serve as RA leader for Franchise Platforms to create and execute the strategy for obtaining registration and CE-marking of new products with the following responsibilities:
* Demonstrate/develop deep domain expertise in the regulatory requirements for EU registrations
* Leads platform SMEs to ensure timely EU registrations; clearly and timely communicating new requirements to the Franchise regulatory team
* Work across the Platforms to create and align on the execution of regulatory strategies with an emphasis on an ability to work with R&D, clinical, quality and regulatory compliance leaders to conduct testing and collect data needed to support EU registrations and CE-marking
* Align with the EMEA regional organization on accountabilities and interfaces to create the regulatory strategy for EU registrations and CE-marking of new products
Leads and supervises EU platform managers
Manage the primary franchise liaisons to key notified bodies
Partner closely with internal partners across Johnson & Johnson (including Marketing & R&D Leaders, EMEA Regional Lead, Clinical and Med Affairs) to ensure that the stakeholders' voices are evaluated within the strategies
Represent CSS in various internal and external forums - including policy (acting as expert on company/product impacts and product advocacy)
Partner with RA Policy Leads to implement new or modified EU regulations and maintain market access
Responsible for communicating business related issues or opportunities to next management level
Responsible for ensuring 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
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
* Advance degree or equiv required (PhD, Masters or equivalent degree with adequate experience)
* 8-10 years of experience required.
* Experience in EU regulatory requirements for medical devices required.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
* Strategic thinking and ability to partner and Influence key stakeholders.
* Expert knowledge of regulatory requirements in the EU and ability to translate regulations into clear data requirements to support CE-marking
* Ability to persuasively communicate with EU regulators (competent authorities and notified bodies)
* Highly skilled in establishing partnerships with regional colleagues
* A strong results-orientation and sense of urgency
* Excellent written and verbal communications skills in English (required) and one other EU language (desired)
* Knowledge and thorough understanding of how regulations impact product registration and market access
* Ability to work effectively in a highly matrixed organization
* Strong people leadership skills
* Connect by cultivating external relationships with regulators in the EU primarily notified bodies and local health authorities and internally collaborating with the Franchise and EMEA regulatory organizations and cross-functionally within the Franchise
* Shape by anticipating and influencing regulatory changes related to current and future Platforms(s) product portfolio in the EU to maximize patient access to innovative Franchise technologies
* Lead by acquiring and developing a diverse team of talented regulatory professionals and transparently communicating in a constructive manner
* Deliver by mobilizing and inspiring an accountable team to deliver results for on-time CE-marking with a global and enterprise-wide mind-set and balance with strategic and short-term goals
Europe/Middle East/Africa-Belgium-Brussels-Capital Region-Diegem
Europe/Middle East/Africa-Germany, Europe/Middle East/Africa-France, Europe/Middle East/Africa-United Kingdom-England, Europe/Middle East/Africa-Netherlands
Johnson & Johnson Medical NV (7546)