What are the responsibilities and job description for the Regulatory Affairs Specialist position at G&H Orthodontics?
Job Summary:
The Regulatory Affairs Specialist will plan and execute global regulatory activities necessary to obtain and maintain regulatory approvals in the US and International markets. In this role, you will ensure compliance with relevant regulations, guidance, and standards, including EU Medical Device Regulation, ISO and other US and global regulations for dental and orthodontic products. You will support the RA team to interact with regulatory authorities to assure timely new product introductions, registration and licensing and continued product access globally. The Regulatory Affairs Specialist will assist in providing regulatory review of labeling and advertising, design changes, and specification changes as well as prepare technical documentation that complies with all applicable regulations.
Essential Duties:
- Develop International regulatory strategies for product submissions
- Assist in keeping company informed of regulatory requirements in the EU and other international markets
- Prepare International submissions - registrations and licensing
- Support product shipping release
- Support RA team with government queries and registration documentation requirements.
- Develop and maintain regulatory affairs department procedures and database
- Writes, reviews and submits technical documents to support product accessibility globally
- Comply with applicable FDA and international regulatory laws/standards
Qualifications, Education & Experience:
- Knowledge of US FDA Medical Device requirements, ISO 13485, EU MDR, and global registration requirements
- Degree in engineering, science or related field
- Working knowledge of global regulatory submissions
- Strong written and verbal communication skills
- Strong technical writing skills
- Ability to effectively manage multiple projects and priorities
- Proven ability to work effectively in cross-functional teams
- 4 year Degree – Required (Bachelor of Science/Engineering Degree preferred); Regulatory Affairs experience (Preferred)