Senior Regulatory Affairs Specialist

Contact name: Selina Maini

Contact email:
Job ref: 519
Published: about 1 year ago
The company

My client is a global medical device company that manufactures and sells medical devices. Their aim is to improve medical discovery and diagnostics. It is a exciting time for the company as they are looking to onboard a Regulatory Affairs Specialist to their dynamic team. This is a full time permanent remote position.

Main Responsibilities
  • Prepare, draft, review, and submit Summaries of Technical Documentation (STEDs) to notified body
  • Assess proposed device modifications for submission to notified body and/or prepare robust non-substantial change justifications for changes that do not require submission.
  • Solicit input and feedback from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.).
  • Represent RA and demonstrate leadership in complex product teams by identifying and interpreting relevant regulatory requirements and providing practical regulatory guidance throughout the product development cycle prior to regulatory submission.
  • Identify and communicate appropriately quantified risks and mitigation approaches associated with regulatory strategies to collaborators.
  • Support development and execution of global regulatory strategies by collaborating closely with international regulatory associates to register our devices worldwide.
  • Lead regulatory efforts required to align with new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards.
  • Review and approve product labeling, promotional materials, and advertising materials to ensure regulatory compliance.
  • Review technical supporting protocols/reports to assure collection of appropriate data for regulatory submissions and regulatory compliance.
  • Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards.
  • Coordinate and respond to requests for product information, and questionnaires requested by customers.
  • Represent the company in relevant external trade organizations and regulatory standards development as necessary to support the companys continuous product development and compliance efforts.
  • Remain current on regulations affecting the company’s products (EU MDR / IVDR reclassification activities, etc.) and keep the relevant team and supervisors informed about potential impact.
  • Identify ways to improve the efficiency of current work process and implement them.
  • Carry out the above tasks with limited supervision.
  • B.S. degree with preference given to technical field (e.g., engineering, bioengineering, biology, chemistry, etc.) or related degree.
  • Minimum 3 years experience in medical device or in vitro diagnostic device companies. Preference in Regulatory Affairs.
  • Proven ability to resolve problems and to make appropriate regulatory decisions under pressure.
  • Demonstrated success in the preparation and completion of regulatory submissions (510(k), STED, technical file, etc.) to global regulatory agencies.
  • Experience in negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical device and in vitro diagnostic areas.
  • Ability to work effectively in a virtual environment.

If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.

Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything