Contura International A/S, is looking for a highly competent and experienced Regulatory Affairs Manager. Contura International – is a Copenhagen based medical technology company that develops, manufactures and commercializes soft tissue fillers based on proprietary hydrogel technology. The facility, which is approved in the US, Europe, Canada, Australia, et al., is designed to fulfil global regulatory requirements and deliver Contura’s entire range of hydrogel products. Contura has recently obtained FDA approval for its product for treating stress urinary incontinence in women, Bulkamid, and a manufacturing license (§39) for production of its hydrogel technology as a medicinal product.
The company’s development, manufacturing and testing processes comply with the European Medical Devices directive 93/42/EEC and the quality system meets the standards required to obtain ISO 13485:2016.
This is the company where you can be part of reaching new heights. You will assist, among others, in the world wide approval of Arthrosamid, a novel long acting hydrogel which received European approval in 2020 for symptomatic treatment of patients with knee osteoarthritis (OA)
The Company Offers:
A challenging position in a company with dedicated people and a strong pioneer spirit.
They reach the objectives through an interdisciplinary collaboration between motivated and competent colleagues in an informal working environment.
There is a natural focus on the ongoing development of your professional and personal skills that will help to ensure the company’s continued success in an ever more demanding area of the medical device industry.
As Regulatory Manager, you will report to the Director of regulatory affairs and Research & Development, and work closely with the team, colleagues from other functions, national as well as international.
As Regulatory Manager you will be responsible for ensuring approval and regulatory compliance of Contura’s products in different areas of the world. You will also be a key driver for Transition of MDD to MDR
Your key responsibilities include but are not limited to:
- Prepare, submit and manage regulatory filings required for product market approval
- Monitor and ensure full compliance with valid legal requirements
- Perform regulatory assessment of changes to product. Determine documentation required to file change notification and submit post-approval changes to regulatory agencies including supplements to FDA
- Ensure Technical files are up to date and MDR compliant
- Ensure regulatory compliance to new as well as current registrations with local, national and international requirements
- Contact and correspondence with external partners in conjunction with actual tasks / projects
- Participate in RA related tasks, such as:
- Regulatory assistance to development projects
- Write, review and approve procedures
- Establish and maintain systems for retrieval of regulatory information
- Regulatory guidance and approval of printed labeling and marketing materials
- Complaint handling and Vigilance reporting
- Contribute to CAPA, NC, CR review, follow-up and any related Root cause analysis
- Trend analysis
- Annual report to FDA.
- Handle contact to competent Authorities, Notified Body, FDA and other relevant authorities in connection with Contura’s product registration
- Handle contacts regarding regulatory issues with customers and distributors
- You have a master´s degree in a relevant natural science and you have a minimum of five (5) years’ experience from Medtech, experience from the pharmaceutical industry is a plus.
- You have a minimum of five (5) years’ experience in a regulatory function.
- You have knowledge of regulatory requirements for medical devices in Europe, the US and worldwide.
- You have experience with, European Medical Device Directive (MDD) and Medical Device Regulation(MDR), ISO 13485 as well as US medical device regulations (CFR 21 part 820)
- Experience in design control will be an advantage
- you have strong communication skills in Danish and English
- Strong communication skills and preferably experience with authorities
- Ability to handle multiple tasks and meet agreed deadlines
- Ability to work intensively in teams and with external parties while maintaining independence and integrity
- Open minded and enjoy teamwork with colleagues from other disciplines
- Hands-on, action oriented
- Positive mindset
Application and further information:
If you would like additional information about this position before applying using the link, please contact Hanne Beirholm, Beirholm Search. Tel. +4529440080 /mail: email@example.com