Sr Manager Quality & Regulatory Affairs

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Healthcare and Medical Devices organization, based in Limburg Netherlands.

My client is a global leader in developing, manufacturing, selling and servicing external defibrillators/monitors and emergency medical response products and services.

ROLE DESCRIPTION

The senior Manager Quality and Regulatory Affairs will be responsible for all Quality Assurance activities for EMEA and for liaising between the company and individual country Ministry of Healths (MoHs) for Regulatory activities. You will be responsible for providing oversight and direction in the areas of Complaint Handling; MDR/Vigilance/Foreign Experience assessments and reporting; Field Corrective Action (FCA) administration; maintaining MoH relationships on the companys behalf; and planning, executing, and reporting on FCA status to both MoHs and the companys headquarters. You must be highly motivated for success, demonstrate critical thinking skills, and be committed to strong cross-functional collaboration.

RESPONSIBILITIES

- Lead, implement, and maintain the quality systems at each location per the global quality system strategy and plan.
- Establish key performance indicators (KPIs) for the Complaint Handling, MDR/Vigilance/Foreign Experience reporting processes.
- Oversee, monitor, and facilitate the submission, approval, and maintenance of medical device license applications.
- Provide expertise and guidance in interpreting and applying governmental regulations, agency guidelines and internal policies to assure compliance, as it pertains to Quality practices.
- Serve as liaison between the Company and various governmental agencies, such as FDA, ISO 3rd party auditors, and local MoHs to provide information related to quality and regulatory activities.
- Work directly with operating entities (Sales, Marketing, Operations, Customer Services, and others) to ensure that inspections and process controls are conducted according to established procedures. Review results and ensure outcomes meet or exceed established requirements.
- Provide leadership, direction, and supervision for the team responsible for Complaint Handling, MDR/Vigilance/Foreign Experience assessments and reporting, and Field Action Administration.
- Represent the organization in a Quality management capacity to other functions.
- Observe and evaluate industry trends and benchmark quality operations against industry standards. Make recommendations and implement changes as needed.
- Provide oversight and governance for quality assurance activities related to supply chain and logistics, specifically the quality system deployment and execution at distribution centers and warehouses globally.
- Perform other related duties as assigned by senior management.

REQUIREMENTS

- Masters degree in engineering, quality management or related scientific discipline or equivalent experience.
- Minimum 10 years work experience in medical device or similarly regulated industry, with a minimum of 7 years management experience.
- Demonstrated successful leadership experience Preferred Qualifications
- Strong working knowledge of FDA QSR, GMPs, ISO, MDD and other Quality System regulations.
- Strong leadership, interpersonal and communication skills (both written and verbal).
- Ability to handle a variety of projects and coordinate the efforts of direct reports at the same time.
- Ability to function in a team environment.
- Ability to work with outside suppliers, medical and technical professionals
- Strong project management skills - Experience as a qualified ISO13485 auditor
- MBA preferred
- Strong leadership and decision making skills
- Ability to travel up to 15% of the time

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.