Regulatory Affairs Associate Director
8 - 10 years experience • Biotech/Pharma
Job Title: - Regulatory AffairsAssociate Director
Location: - Hampton, NJ
Travel: Home based location. Frequent on-site work at facilities in Buffalo, New York and Arlington, Vermont required. More than 70% travel anticipated.
Position Summary :
- Implements regulatory strategies for worldwide Pre-market Notification and individual country/region Market Authorization aspects of marketed devices, filing necessary applications and handling government interactions pertaining to the regulation process for products requiring governmental approval. Partner with and actively support team, providing structure to ensure that the development meets regulatory requirements and that the teams are able to efficiently achieve goals and attain necessary regulatory clearances/approvals, providing a robust documentation “package” at appropriate, planned submission points.
- Interprets and applies applicable laws, regulations and guidelines governing devices and drugs, to meet business objectives for Therakos Project Team – 10%
- Formulates and implements regulatory strategies, in conjunction with business objectives, and translates plans into operational deliverables (i.e. submissions); assesses and communicates device regulatory requirements to ensure development activities are in compliance with applicable regulations and guidelines; manages regulatory activities in respect to quality and timeliness. – 40%
- Interacts with health authorities on guidance, submission and review of device products and projects; directs the preparation of and prepares worldwide device submissions to health authorities and ensures the quality and content of submissions. – 5%
- Advises the Project Teams on regulatory issues concerning the Therakos Project deliverables. – 10%
- Partners with internal departments and ensures development plans meet regulatory requirements and guidelines. – 15%
- Monitors, reviews, and analyzes development of new requirements and regulations and provides input on potential impact on the Therakos Project products/projects. – 10%
- Considers and recommends any necessary changes to policies and procedures to ensure regulatory compliance;- 10%
- Bachelor’s degree in a scientific discipline
- Experience: 8 to 10years regulatory affairsexperience in the medical device industry. Hands-on experience determining data requirements and leading groups charged with preparing device submissions activities for clinical trial and/or marketing applications
- Solid working knowledge of device regulations for the US, Canada and EU; familiarity with device regulations for rest of world; familiar with a variety of medical devices concepts, practices, and procedures and the functions of a device regulatory affairs department. Strategic and operational skills in reading and interpreting applicable laws; strong organizational skills; excellent written and verbal communication, negotiation/persuasion, and interpersonal skills; detailed oriented.
Certifications/Licenses: Regulatory Affairs Certification (RAC) desirable