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Based in the European HQ in Belgium, the Regulatory Affairs Manager reports to the Director, Regulatory Affairs, Global & EU.
This position develops and implements regulatory strategies and processes to assure timely global commercialization of CSS products in compliance with applicable European regulations and international standards.
Randstad’s mission is to shape the world of work by being a world leader in matching supply and demand in the labor market and in HR services. Randstad Professionals is part of the Randstad Group and creates opportunities for highly qualified and skilled professionals to work on successive projects on customers’ site. For you as specialist, Randstad Professionals wants to become a personal career coach, a purposeful networker and a mentor who sees to it that your expertise stays up-to date.
Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• The Manager, EU Regulatory Affairs develops and implements regulatory strategies and processes to assure efficient processes and documentation of new requirements for CSS products in compliance with applicable Regional Regulations and international standards: o Leverage deep knowledge of the regulatory environment, including compliance, current and proposed laws regulations, standards, directives, guidance, Notified bodies position paper. o Provides strategic guidance to CSS to assure efficient processes and documentation of new requirements for CSS products o Provides advice, counsel and expertise on RA and compliance issues in a team environment, both proactively as well as reactively o Assists the RA platform for any questions related to the new requirements and develop recommendations pertinent to the CSS portfolio o Ensures vigilance of Environmental regulations and their outcomes for CSS products o Provides training on new regulations to the RA platform on his/her topics of expertise o Represents CSS in various internal and external forums for the platform o Serves as a consultant, making recommendations and corrective actions, and supports audits from a regulatory perspective (internal and external) o Authorizes shipment of pre-CE marked devices for clinical studies • The Manager, EU Regulatory Affairs supports daily RA activities related to products under his/her portfolio: o Serves as a EU regulatory SME for the portfolio under his/ her responsibility and provides / monitors any specific regulations inherent to it. o Partners closely with internal partners across Johnson & Johnson (including regional platform regulatory (legal manufacturer), Clinical, Medical Affairs, Quality, Product environmental o stewardship, Marketing Lead, Commercial, Clinical and Med Affairs…) to ensure well defined regulatory strategies for products launch and modifications o Notifies RALI and EU Registration Team representative to ensure timely registration of new products launch and products modifications o Approves ECO’s pertaining to the Manager’s projects and duties (including but not limited to SOPs, EU labeling approval) o Reviews EMEA internal and external communications that reference products and/or disease state information in accordance with EU regulations (Copy Review Process) o Controls the distribution of medical devices in accordance their regulatory requirements and registration status (item restriction) o Supports customization activities in the European Distribution Center (Late Stage Customization o process) • The Manager, EU Regulatory Affairs is: o Responsible for communicating business related issues or opportunities to next management level o 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 o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Responsible for defining training curriculums assignments for associates o Responsible for communicating business related issues or opportunities to next management level o 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 o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures o Performs other duties assigned as needed
EXTERNAL AND INTERNAL INTERACTIONS
• Interaction with External Manufacturers • Interaction with Ministries of Health • Interaction with Sponsors/Manufacturers Regulatory Affairs counterparts cross franchise, Clinical Operations Departments, Johnson & Johnson local regulatory affiliates in EMEA, J&J owned pharmaceutical entities, quality department, technical department, finance and human resources, Regulatory Policy, medical sciences, and various working groups
• Bachelor’s degree with 5-8 years of experience or PhD, Pharm, Masters, legal degree with adequate experience required. • Advanced degrees and education in medicine, engineering, science or law preferred. • Adequate 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 EU registrations • Ability to persuasively communicate with EU authorities • Highly skilled in establishing partnerships with regional colleagues • A strong results-orientation and sense of urgency • Fluent in English (required) and in another European language (desired) • Acute analytical skills and sharp regulatory interpretation abilities • Tactful attitude towards customers • Assertiveness – problem solving • Conscientious • Connect by cultivating external relationships with EU authorities, notified body and internally collaborating with the Platform commercial organization • Shape by anticipating and influencing product specific guidelines and standards. • Lead by providing guidance to a team of talented regulatory professionals and transparently communicating in a constructive manner • Deliver by mobilizing and shaping requirements in technical documentation to deliver results for on-time EU registrations
what do we offer?
As an answer to your high level of education and flexibility, Randstad Professionals offers you a salary package on level, with extra-legal advantages: - Meal vouchers - Hospitalisation insurance - Group insurance - Representation cost - Development opportunities