Associate Director, Regulatory Affairs
Proclinical is currently recruiting for an Associate Director of Regulatory Affairs with an award-winning biomedical device company located in Center Valley, PA. As the Associate Director, you will be responsible for obtaining and maintaining AIC and AIS product registrations, clearances and approvals through the US Food and Drug Administration.
- Assists the Vice President of Regulatory Affairs in executing RA responsibilities in accordance with all applicable laws and corporate policies.
- Assists in the development of RA goals/objectives (MBOs). Responsible for meeting/exceeding MBOs.
- Develops/implements processes, procedures and metrics to effectively manage RA activities.
- Responsible for weekly, quarterly and annual reports for RA.
- Coordinates company-wide announcements related to RA.
- Works with legal counsel, consultants and other experts, as required.
- Interacts with US FDA, industry groups (AdvaMed, OSMA), corporate partners and vendors.
- Assists Regulatory staff and cross-functional teams to aid in the development of Regulatory strategies to ensure timely product registrations, approvals and clearances.
- Reviews and approves submissions to the US FDA.
- Manages and disseminates Regulatory Intelligence and training to RA staff and other stakeholders.
- Assists in the development and review of product labeling, packaging, advertising and promotional information.
- Organizes RA department meetings. Addresses departmental and other Regulatory issues and problems. Recommends appropriate courses of action to Executive Management, as necessary.
- Manages facility registrations.
- Assists Quality Assurance with FDA inspections and internal/ external audits.
- Must comply with applicable ISO and FDA regulations as stated in Quality Manual
- Must embody the Company's Vision, Mission and Values
- Other duties may be assigned
Skills and Requirements:
- Requires excellent written, oral, and interpersonal communication skills.
- Computer skills in Windows, MS Word, Excel, and Power Point.
- Must be able to travel by automobile, train, and airplane, and work occasional weekends.
- Contribute to creating a climate of trust, ethics, and accountability by effectively seeking out and accepting feedback from others.
- Possess the ability to exceed expectations with the customer in mind and take responsibility for driving key results as well as empower others to achieve desired outcomes.
- Demonstrate behaviors that drive efficiency by understanding and improving processes as well as sharing best practices.
If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at (+1) 424-361-3900 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.