Regulatory Affairs Specialist, 1930 Zaventem

Company details

Profile Group is a premium Selection and Recruitment company that has been helping candidates in their job search for 30 years. Working with a wide variety of companies, we provide candidates with a high quality service that helps both in the application process and improving the various skills required to succeed in interviews.

Our client is seeking a Regulatory Affairs Specialist, 1930 Zaventem

Function

Your Role:

Do you want a career path in an innovative international company where no two days are alike?

Are you ready to be a key talent in International Regulatory Filings for medical device products and procedures?

Do you want to be a key point of contact for enabling the regulatory compliance in the Markets?

Your Key Responsibilities:

• You support multiple global projects by taking ownership for setting up and maintaining all regulatory files in Europe, AFLAME and APAC
• Extensive contact with the Sales and Marketing Team
• You conduct team meetings and ensure deadlines are met by creating an action plan for all new products needing to be registered
• You are responsible for preparing and submitting product registration files to obtain or to maintain marketing approval and to ensure compliance with import regulations
• You manage the coordination of all necessary documents required (CE certifications, Declaration of Conformities, IFU’s,….) to obtain requested licenses, notarizations, apostille, foreign embassy authentications
• Approval process in WindChill and SAP
• Contact with distributors to verify Product Change Notifications
• Follow up on new regulations in all regions.

Profile

• Minimum 2 years’ experience in Regulatory Affairs
• Familiar with 510 (k) submissions, PMA, or international documents or registration and marketing of medical devices worldwide
• Working knowledge of medical device regulations (21 CFR), FDA Law, EU MDR
• Experience in supporting international registrations and clinical investigations is an asset
• Excellent English (written & spoken)
• You are a highly proactive team player who wants a varied role in an international company

Offer

• Competitive Salary + Individual and Company Performance Bonus, Positive Evaluations linked to Salary Increases, Company Car Possibility, Lunch Vouchers, Pension Plan and Health Insurance
• 2 Days Teleworking
• Work/Life Balance
• Company pro Training hence Personal Development Budget and Career Path (50% of open positions are filled internally)