Senior consultant Compliance & Regulatory Affairs
To instruct, coach and facilitate project teams on the application of Regulatory Affairs. The application of legislation, standards and guidelines relevant for product development and manufacturing.
To engage with PInS sales as well as PInS customers related to the identification of relevant regulatory and compliance boundary conditions for the PInS assignment during the definition phase.
To provide guidance and coaching to PInS development teams in order to work in line with applicable Quality Management Systems (QMS). This can be QMS of Royal Philips or PInS, or the QMS of the customers.
To identify risks of non-compliance in an early stage of the project and escalate these appropriately.
To define, evaluate and get approval of the Project Quality Plans including Risk-Safety-Hazard analysis.
Assists with establishing a structure and control measures for the project related documentation, the creation of relevant records and configuration management, (DHF, DMR, DHR and TPD documentation).
Assisting the Project Leader in creating and maintaining the Product Risk Management and the Verification & Validation plans.
Creating, maintaining and reviewing (project and/or production) of Quality documentation, such as Quality & Regulatory documents, reports, procedures, work instructions, in line with the request of the customer and the applicable QMS.
Assists with the preparation and approval of milestone review meetings by collecting the status of all deliverables relevant for Quality and Regulatory aspects.
Assists with the preparation and review of relevant documentation for regulatory submission like 510K.
To join and support the PInS Community of Practice (CoP) on Medical Compliance.
Give training on Quality and Regulatory matters to PInS employees, Customers or relevant Suppliers on PInS projects.
To identify, initiate, execute and/or follow up actions to further build the Regulatory and Compliance competence within PInS.
To prepare, conduct and/or support internal as well as external (supplier) Quality Audits.
To prepare and support PInS and her project teams in Quality Audits.
Required Capabilities :
Good knowledge and understanding of ISO 9001:2015, ISO 13485:2016 and ISO 14971:2016.
Good insights in regulations within MDR and 21CFR820, as well as standards and directives as IEC 62366, IEC 62304, IEC 60601 and other legislation, standards and directives related to product realization and submission within the Medical Field.
Being able to support PInS with the identification and prioritization of compliance issues as well as the development and implementation of compliance plans.
You have a Bachelor’s or Master’s degree in relevant area of expertise; Discipline like Physics, Mechanical, Electrical and/or Industrial Engineering.
Experienced in the complete life cycle of product development and innovation (e.g. front-end development, product definition, claims development (medical), to product creation, realization, disposal)
An excellent understanding of EU and US Medical Device Regulations (MDR/FDA), Quality Management System (QMS) requirements and other relevant Quality and Regulatory legislation, standards and guidelines.
Experience with Compliance and Risk Management methodologies such as Design and Process FMEA, Health Hazard Analysis (HHA), Fault Tree Analysis end other relevant techniques.
Capable in translating the abstract Regulatory, QMS or Quality standard requirements into ‘hands on’ actionable items for specific NPI projects.
Capable of decision making on which Regulatory, QMS or Quality standard requirements are applicable in a NPI project.
Capable of explanation of the rationale behind Regulatory and Quality requirements.
You are flexible and can easily adapt to changes (in projects, organizations, …)
You are an excellent and convincing communicator to people reaching out for advice
You are open to gain further competences within the Field Regulatory Affairs (RA).