CardioMed Device Consultants- Principal Consultant
BDC Laboratories · Edgewater, MD · 5 mo ago
RemoteRemoteConsultingFull-time
About the role
This position offers a dynamic opportunity for a Principal Consultant to join CardioMed Device Consultants. The ideal candidate will bring extensive experience in device development and regulatory affairs.Responsibilities
- Lead the development and implementation of regulatory strategies for new medical devices.
- Collaborate with cross-functional teams to ensure compliance with FDA and international regulations.
- Prepare and submit clinical trial applications and obtain necessary approvals from regulatory bodies.
- Manage the pre-market review process and address any issues that arise during the submission phase.
- Provide guidance on device design and manufacturing processes to ensure product safety and efficacy.
Requirements
- Bachelor’s degree in Biomedical Engineering, Medical Technology, or a related field.
- Minimum of 10 years of experience in medical device industry, with at least 5 years in regulatory affairs.
- Strong understanding of FDA and international regulatory guidelines.
- Excellent written and verbal communication skills.
- Ability to work independently and manage multiple projects simultaneously.
Qualifications
- Proven track record of successful regulatory submissions and approvals.
- Experience in managing clinical trials and obtaining regulatory clearances.
- Knowledge of medical device design and manufacturing processes.
- Ability to work effectively in a team environment.
Skills
- Strong knowledge of medical device regulations.
- Excellent organizational and time management skills.
- Proficient in Microsoft Office Suite.
- Ability to communicate effectively with regulatory agencies and stakeholders.
Benefits
- Competitive salary commensurate with experience.
- Flexible working hours and remote work options.
- Inclusive benefits package including health insurance, retirement plans, and paid time off.