Regulatory Affairs Manager

ref: 06068


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 Medical Devices and Pharmaceutical organization, based in Noord-Holland Netherlands.
Our client is know for its highly innovative coating and surface protection fluids. The site of my client in the Netherlands is the centre of the Medical Devices department of the bigger company and their products are sold worldwide.

Role description

You are proactively monitoring the latest legislation and regulations in in the field of Pharma and Medical Devices and regulations that are close knit to these regulations. You will be the contactperson for external stakeholders as for instance Notified Bodies, or Nefemed. You will be of support to professionals in the company regarding compliancy questions and regulatory challenges.

Responsibilities

- Updating of Regulatory requirements
- Pre market Regulatory activities
- Post market Regulatory activities
- Spokesperson for Notified Bodies
- Advising Business Manager on RA topics
- Formulate and implement RA policy
- Responsible for DMF

Requirements

- Bachelor Industrial Pharmacist, Biopharmacist, Chemistry
- At least 5 years of experience
- Experience in Pre/Post market Regulatory Affairs
- Independent working attitude
- Familiar with international environment
- Languages spoken, written, understood: English and Dutch
- Proactive

Secondary benefits

  • Pension Plan
  • Travel Allowance
  • Laptop
Country
Netherlands
Region
Noord Holland
Sector
Pharmaceuticals, Medical Devices
Specialization
Regulatory Affairs, Continuous Improvement
Employment type
Permanent
Experience
6-10 Years
Education
Bachelor
Location type
On location
Salary
70.000 Eur - 80.000 Eur
Language
English, Dutch