Regulatory Affairs Specialist
Regulatory Affairs Specialist
Posted on :
20-06-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Responsibilities:
- Preparing documentation for international regulatory registrations.
- Preparing technical documentation compliant to MDD and EU MDR.
- Defining worldwide regulatory requirements necessary for regulatory approval of products.
- Participating on cross functional teams as regulatory lead.
- Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages.
- Authoring submissions researching requirements setting priorities and maintaining project schedules.
- Providing guidance and oversight to team members related to regulatory compliance.
- Reviewing marketing literature for compliance to applicable regulations.
- Executing on additional responsibilities as defined by management.
- Act as a Subject Matter Expert (SME) to support internal and external audits.
- Bachelors degree in science Engineering or other relevant discipline.
- Minimum 5-8 years experience in Regulatory Affairs in the medical device industry.
- FDA EU Health Canada and international registrations experience.
- Working knowledge with quality system regulations and guidelines.
- Ability to develop clear concise and timely oral and written reports.
- Great communication skills with all levels of personnel.
- High level of organization and planning skills.
- Working knowledge of medical devices procedures and terminology.
- Drug-combination experience a plus.
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
