Piper Clinical is currently looking for a Regulatory Affairs Specialist in West Chester, PA to work for a cutting edge global medical device company focused on orthopaedic and neuro products and services, to assist in providing regulatory expertise to new product development.
Responsibilities for the Regulatory Affairs Specialist Include:
- Provide regulatory expertise to new product development
- Sustain engineering team’s preparation and submission of regulatory documentation for product registration and licensing in Wave 1 and 2 countries.
- Engage with cross-functional teams to obtain relevant information and review of submission content.
- Assist in preparation of global registration dossiers
- Support compliance activities related to global regulations and international standards.
Qualifications for the Regulatory Affairs Specialist Include:
- 4-6 years of regulatory affairs or related/equivalent experience
- Strong understanding of Risk Management process and Remediation activities
- RAC accreditation (through RAPS)
- Knowledge of US regulatory and CE mark pertaining to Technical Files and Design Dossiers, ISO 13485, ISO 9001, MDR, MEDDEV, QSR,
- Bachelors degree from accredited college or university
Compensation for the Regulatory Affairs Specialist Includes:
- Salary Range: $125,000-$140,000 based on experience and education
- Full Benefits: Cigna Healthcare, MetLife Dental, VSP Vision, 401(k) with Voya, and Paid Time Off