(+45) 29 44 00 80 / kontakt@beirholmsearch.dk

Regulatory Affairs Coordinator

Regulatory Affairs Coordinator
maj 17, 2022 Hanne Beirholm
contura job

Be a part of Contura International’s success and growth as Regulatory Affairs Coordinator (RA C).

Be a part of Contura International’s success and growth as Regulatory Affairs Coordinator (RA C).

In this exciting new role, the RA C is responsible for ensuring that Contura’s unique products, which make a meaningful difference for patients, are made available worldwide in accordance with regulatory requirements and for coordinating the processes in this regard.

You will provide coordination, supervision and focus to execute all activities in alignment with regulations and time frames.

Are you the proactive and competent colleague who approaches projects with a team players’ spirit and positive drive and stays on top of ongoing projects with a problem-solving mind?

And are you also good at working independently and able to plan, structure and drive your own tasks?

No one is a champ from the get-go, but if you have a few years of experience within Reg. Aff. and the industry, the will, and the potential, we will give you a steep learning curve.  And if you like to work for a company who, besides the business, also love to have fun and celebrate every step ahead, this might be the right job for you.  🙂

The role and responsibilities:

You will refer to and collaborate closely with the RA/R&D Director and the talented group in Regulatory Affairs, manufacturing, Quality Assurance, R&D, as well as with external stakeholders

The coordination as well as active player of all regulatory actions being implemented:

  • Handle contact to competent Authorities, Notified Body, FDA and other relevant authorities in connection with Contura’s product registrations.
  • 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 and DHF 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.
  • Write, review and approve procedures
  • Regulatory guidance and approval of printed labeling and marketing materials
  • Work as a regulatory resource in development projects

Professional Competences:

  • You hold a degree in natural science or equivalent
  • 2-3 years’ experience from Regulatory Affairs in a similar job, preferably with medical devices and some knowledge of MDR, ISO 13485.
  • Excellent knowledge of MS Office
  • Good verbal and written communication skills
  • Fluency in Danish and English

Personal Competences:

  • Communicate effectively
  • Contribute to good team spirit in the department and in Contura
  • Well-organized, flexible, pro-active
  • Ability to work independently as well as in a team matrix organization and multiple projects
  • Ability to maintain a good overview when working on multiple tasks and meet agreed deadlines
  • Open minded and enjoy teamwork
  • Able to work in a fast-paced environment with changing priorities
  • Able to identify and resolve issues

Contura:

Contura is a Copenhagen based medical technology company that develops and manufactures innovative medical products in the fields of orthopedics, women´s health, soft tissue augmentation and animal health using its unique, patented hydrogel technology.

The manufacturing facility, which is approved in US, Europe, Canada, Australia, etc., has been uniquely designed and fulfils global regulatory requirements to deliver Contura´s entire range of hydrogel products.

For more information about the company, please visit www.Contura.com.

Application:

For additional information please contact Beirholm Search at kontakt@Beirholmsearch.dk or Hanne Beirholm at tel. 29440080.





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