Job Title: Regulatory Affairs Specialist
About the Role
This role offers a unique opportunity to develop your expertise in regulatory affairs and contribute to the success of our organization.
* You will be responsible for managing regulatory submissions worldwide, ensuring compliance with international regulations, and maintaining effective relationships with regulatory agencies.
* Assist in implementing MDSAP within the organization and support the team in obtaining and retaining country-specific regulatory registrations globally.
* Work closely with interdisciplinary teams to ensure the effectiveness of quality management systems (QMS) and product development plans.
* Maintain post-market surveillance activities, including logging customer complaints, coordinating investigations, and conducting regulatory trending and reporting.
* Evaluate manufacturing and labeling changes, promotional materials, and global regulatory trends to ensure compliance with applicable regulations.
Required Skills and Qualifications
To succeed in this role, you will need:
* A bachelor's degree in engineering or science with a minimum of 3 years of experience in regulatory affairs in the medical device industry.
* Regulatory certifications in EU MDR and US FDA are desirable.
* A thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CFR 820, and supporting standards.
* A proven track record of successfully managing projects to deadlines and experience working directly with regulatory agencies.
Benefits
We offer a competitive salary, bonus, pension, healthcare, and excellent opportunities for professional growth and development.
About Us
We are a leading company in the medical device industry, dedicated to developing innovative solutions that improve patient outcomes. If you are passionate about regulatory affairs and want to make a meaningful contribution to our organization, we encourage you to apply.