Johnson & Johnson
BE -Associate Director Regulatory Affairs - Medical Devices
Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.
We are currently recruiting an Associate Director Regulatory Affairs for a pregnancy replacement of a permanent employee until January 2022.
For this position you do not leed to live in Belgium, we are open for all candidates who live in an EU country.
Based in the European Union, the Associate Director, Regulatory Affairs Strategy develops and implements regulatory strategies and processes to assure timely global commercialization of CSS products in compliance with applicable European regulations and international standards. Exhibiting expertise in EU regulations regarding product design, development, manufacture and distribution, the Associate Director, Regulatory Affairs Strategy monitors and assess the impact of product specific regulations.
The Associate Director, Regulatory Affairs leads the strategy for CSS, including registration of manufacturer or Authorized Representative for Franchise businesses.
DUTIES & RESPONSIBILITIES:
- Leads and develops a team of RA professionals who accelerate registrations and CE marking including registration for multiple franchise businesses.
- Educates franchise Associates on EU requirements and integrating those requirements into franchise procedures.
- Serves as RA leader for Franchise Businesses to create and execute the strategy for obtaining registration and CE-marking of new products.
- Develops and leads the regulatory strategy for economic operator and supply chain initiatives for CSS.
- Demonstrates deep domain expertise in the regulatory requirements for EU registrations .
- Leads Franchise SMEs to ensure timely EU registrations; clearly and timely communicating new requirements to the Franchise regulatory team.
- Works across the Businesses 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 registrations and CE-marking.
- Directs and coordinates activities concerned with the submission and approval of products covered by virtual manufacturing agreements to Notified Bodies, including guidance to project team members regarding regulatory strategy, compliance issues and oversight of the preparation and maintenance of regulatory submissions and files.
- Reviews EMEA internal and external communications that reference products and/or disease state information in accordance with EU regulations (Copy Review Process).
- Oversees and supports the process for the control of the distribution of medical devices in accordance their regulatory requirements and registration status (item restriction).
- Oversees and supports customization activities in the European Distribution Center (Late Stage Customization process).
- Ensures adherence to standard operating procedures and protocols, and adjusts processes to improve efficiency or align with compliance requirements.
- Is the Regulatory contact person for Competent Authorities in the European Union representing Franchise businesses (European Authorized Representative) for CE marked devices, according to Authorized Representative Agreements in place and per applicable processes. This includes acting as the AR Person Responsible for Regulatory Compliance (AR PRRC) according to Regulation (EU) 2017/745 on Medical Devices.
- Supporting announced and unannounced inspections of the premises of the authorised representative.
- Partner closely with internal partners across Johnson & Johnson (including Legal Manufacturers, Importers, Distributors, Marketing, R&D, Regional Leaders, Quality, Clinical and Medical Affairs) to ensure that the stakeholders' voices are evaluated within the strategies.
- 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.
- For those who supervise or manage a staff, responsible for ensuring that 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, if applicable.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Performs other duties assigned as needed.
EXPERIENCE AND EDUCATION:
- Advance degree or equivalent degree required (PhD, Masters or equivalent degree with adequate experience).
- 8-10 years of professional experience in regulatory affairs or in quality management systems relating to medical devices experience in EU regulatory requirements for medical devices required.
REQUIRED KNOWLEDGE AND SKILLS:
- 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.
- Connect: by establishing relationships with a broad set of diverse colleagues, externally with regulators in the EU, and internally collaborating with the Franchise and EMEA regulatory organizations and cross-functionally within Franchise and across HMD. Responsible for seeking out and incorporating diverse points of view into strategies and solutions.
- Shape: by anticipating and influencing regulatory changes related to current and future product portfolio in the EU to maximize patient access to innovative Franchise technologies. An ability to drive and adapt to change, navigating through ambiguity and supporting the business in finding innovative solutions to meet regulatory needs and business priorities.
- Flexible working hours.
- You will work remotely because of COVID-19.
- This is a contracting position. You will receive a contract via our partner Ausy. Ausy can offer you a project contract for the duration of the assignment at J&J or a freelance contract.