Senior RA Program Lead

Location Diegem
Discipline: Medical Device
Contact name: Isla Littlewood

Contact email: i.littlewood@panda-int.com
Job ref: 19724
Published: 18 days ago

Senior RA (Regulatory Affairs) Program Lead, Strategic Programs – MDR (medical device regulations)

 

The Senior RA Program Lead, Strategic Programs – MDR is a critical position responsible for ensuring the consistent application of regulatory interpretation and implementation for programs such as the EU MDR and associated secondary legislation within the Cardiovascular & Specialty Solutions (CSS) Business Units.

With a good knowledge of Regulatory Affairs in the EU, this role will proactively coordinate and track the alignment of country-specific activities and liaise with relevant cross-functional stakeholders to support regulatory MDR Project deliverables for CSS.

 

Your responsibilities:

  • Provides strategic guidance to CSS related to regulatory requirements and develops recommendations pertinent to the Franchise in accordance with regulations and relevant guidelines
  • Ensures the timely execution of regulatory implementation activities and associated projects
  • Provides clear and timely communication of new and changing requirements to the Franchise regulatory teams
  • Educates Franchise Associates on EU requirements and integrating those requirements into Franchise procedures
  • Organizes and maintains reporting schedules, trackers and systems
  • Develops and sustains relationships with RA affiliates, contributing to the development and execution of local strategy. This includes planning, prioritization and preparation of responses to regulatory agencies' questions and other correspondence
  • Drives consistency across all businesses within CSS and across MedTech for technical documentation creation and adherence to procedures
  • Supports the creation of technical documentation for products within the portfolio to ensure continued knowledge, understanding of challenges and process improvements throughout the program
  • Supports the project plan and schedule to ensure all regulatory interdependencies are understood and accounted for in the overall schedule
  • Develops and maintains constructive and cooperative working relationships with business functions in the organization
  • Identifies and facilitates continuous improvement activities
  • Represents CSS in various internal forums
  • Develops solutions to a variety of problems of extreme complexity in which data analysis requires an evaluation of intangible variables
  • Writes, reviews and revises company SOPs as required, recommending adjustments to processes to improve efficiency or align with compliance requirements
  • Responsible for communicating business related issues or opportunities to next management level
  • For those who supervise or manage 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

 

Your profile:

  • University degree in Science, Engineering, Technical or Biomedical field or Law (or equivalent degree with adequate experience)
  • 6-8 years’ experience in Regulatory Affairs or other related discipline in the medical device or pharmaceutical industries
  • Good knowledge of medical device regulatory requirements in the EU
  • Ability to work effectively in a highly matrixed organization
  • Project Management Skills
  • Strategic thinking and ability to partner and influence key stakeholders
  • Highly skilled in establishing partnerships with Regional and Franchise colleagues
  • Strong communication, influencing and presentation skills
  • Strong results-orientated and sense of urgency
  • Strong ability to build constructive and cooperative working relationships
  • Excellent written and verbal communications skills in English (required)


Practicalities:
  • Location: Diegem, BE
  • Hybrid work model: 2 days per week in office
  • Start date: ASAP
  • Contract: Initially 1 year, high possibility for extension


???????For more info, please contact Isla Littlewood at +31 20 20 44 502 or i.littlewood@panda-int.com.