What are the responsibilities and job description for the Regulatory Affairs Specialist position at Integration International Inc.?
Job Title: Regulatory Affairs Specialist – Sr
Type: 18-month Contract
Pay: $39.85/hour (no benefits)
Location: Remote (EST/CST preferred; Memphis preferred)
Looking for someone preferably with EU MDR submission experience and 510k experience is not required but would be an added bonus
- Prepare and review global regulatory submissions (US 510(k), EU technical documentation, international filings).
- Lead regulatory strategy for new and modified medical devices to support timely product launches.
- Manage regulatory projects and ensure compliance across global markets.
- Support audits and communicate with regulatory authorities as needed.
- Evaluate regulatory impact of product, design, labeling, and manufacturing changes.
- Maintain global regulatory knowledge and ensure compliance with standards and guidelines.
- Develop SOPs and ensure adherence to regulatory requirements.
- Provide guidance, training, and mentorship to cross-functional teams.
- Review labeling for regulatory compliance and support market expansion activities.
Salary : $39