Piper Companies is currently looking for a Regulatory Affairs Consultant in West Chester, PA to work for one of the largest medical device companies globally 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)
- Proven work experience with writing and authoring 510K
- Knowledge of US regulatory and CE mark pertaining to Technical Files and Design Dossiers, ISO 13485, ISO 9001, MDR, MEDDEV, QSR,
- Bachelors Degree in Life Sciences or related degree
Compensation for the Regulatory Affairs Specialist Includes:
- Salary Range: $125,000-$135,000 based on experience and education
- Full Benefits: Cigna Healthcare, MetLife Dental, VSP Vision, 401(k) with Voya, and Paid Time Off
Please send all qualified resumes to Karen Pallone at firstname.lastname@example.org