Regulatory Affairs Specialist
We are currently looking for a Regulatory Affairs Manager for our Pearl River, NY office.
The Regulatory Affairs Manager will be responsible for assisting with management of the Regulatory Affairs department activities. Specifically, responsible for:
- Competent Authority Interaction and Management
- Preparation of clinical trial study reports
- Maintenance of Clinicaltrials.gov website
- Assuring compliance with domestic and international regulatory requirements
- Assistance with design and implementation of clinical trials to support new and existing products
Responsibilities include but are not limited to:
- Ensure that all clinical study reports, CA submissions and other submissions as requested meet regulatory requirements.
- Participate in preparation and submission of regulatory submissions to obtain approval to conduct domestic and international clinical investigations and to seek regulatory approval to commercialize the new and existing devices and their accessories. (IDE supplements, PMA, Annual reports, change notice etc)
- Assist in design and implementation of clinical studies in support of new and existing products. Act as liaison with clinical function.
- Maintain knowledge base of existing and emerging regulations, standards, or guidance documents and provide interpretive assistance to cross-functional teams.
- Prepare and update SOPs/QMS documents to ensure compliance with all applicable US and international regulatory requirements
- Participate in regulatory inspection/audit activities with regulatory agencies.
- Bachelor’s degree required.
- Master’s degree in Regulatory Affairs or Clinical Research preferred.
- Minimum 6 years’ experience in Regulatory area, Clinical Operations or related experience OR a Masters in Regulatory Affairs or Clinical Research.
- Good working knowledge of domestic and international requirements and regulations and experience managing regulatory projects.
- Excellent organizational skills and analytical and problem-solving abilities
- Strong verbal and writing skills and good interpersonal and leadership skills
- Strong PC skills include MS Word, Excel, Visio, PowerPoint, MS Project, SharePoint and internet.
- Competitive Salary
- Company Paid Medical Benefits
- Vacation & Sick days
- Career Advancement
Learn more here
Job posted: 2020-03-19