Regulatory Affairs Associate

Job title:

Regulatory Affairs Associate

Company:

Serrix Consumer Health

Job description

Do you have a passion for drawing up technical documentations for Consumer Health Products and ensure that these documents remain up to date? Then you may be who we are looking for!RA Associate | 32-40 uur | On siteSerrix was founded in 2007 and focuses on the development, sales and marketing of consumer health products.We have brought 3 self-developed and patented leading brands onto the market with a small and enthusiastic team of 10 people. We do everything ourselves and are proud of it! It means visibility every day of the work you put into it. And according to a vision and above all hands-on, feels like taking the Serrix brands to the next level.The positionThe RA Associate position is an important position. This position involves both analytical elements as well as hands on approach to various projects.Technical Documents: For the TD you coordinate changes that impact the TD. This contains:Perform desk research for and assist in writing Clinical and Biocompatibility Rationales for product technical documents.Database searches on specific ingredients for supporting evidence.Develop efficacy evaluations, develop clinical evaluations, develop safety evaluations, develop risk management evaluations and develop clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports (as per Medical Device guidelines).Keep the TD’s up to date to regulations and standards. Coordinate changes that impact the TD (incl assessment whether or not change has an impact on the Technical Documentation.Market Access: Support in country registrations (via distributors). This contains the countries where Serrix is active outside the EU.In short: a broad role in which you deal with all facets of the Technical Documentation. The role consists of a lot of reading work, drafting texts, but also contains a large administrative component.Where you are going to work?Serrix is an entrepreneurial company with a proven track record in the development and sales of innovative and effective OTC products. Our expertise lies in the field of product development, registration, the set up of supply chain, and sales & marketing through our international distributor’s network in over 25 countries. Serrix is located in the centre of Amsterdam. You will report to our QA/RA Manager.Our key values:

• Leadership
• Transparency
• Pride

Your profile:

• MSc in pharmacy, biochemistry, biology or equivalent;

• You have 2-4 years of work experience;

• Experience in writing English scientific texts;

• You have affinity with the Medical Devices industry;

• You are eager to learn;

• Willing to work in a smaller organization;

• You are living in or near Amsterdam;

• You are authorized to work in The Netherlands.

What do we offer you?We understand a good remuneration as more than a good salary. Enjoying your work and a good work-life balance are just as important. The more you enjoy yourself, the better your contribution to our products. You therefore get plenty of opportunities to develop yourself further, to organize your time in and outside the office. Serrix invests in training and education of its employees.

• Be part of a culture where ideas are valued and initiative is encouraged;

• Professional, passionate and dynamic organization of driven colleagues with an office in a beautiful location in the heart of Amsterdam;

• Good salary based on your experience;

• Good secondary benefits and fun outings with the team.

SolliciteerWil je ons team komen versterken als RA Associate? Dan horen we graag van je!Acquisitie naar aanleiding van deze vacature wordt niet op prijs gesteld. Recruitmentbureaus (uitzendbureaus, detacheringsbureaus, werving en selectiebureaus en/of overige intermediair) kunnen geen rechten ontlenen aan het ongevraagd doorsturen van CV’s. Deze CV’s zullen wij als eigen sollicitaties behandelen.

Expected salary

Location

Amsterdam, Noord-Holland

Job date

Sat, 10 Aug 2024 22:09:28 GMT

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