Regulatory Affairs Specialist II - Molecular LLC - United States
Provide pre-market regulatory strategy and implementation to ensure regulatory approval objectives that support commercial initiatives for new and modified products. Supports applicable regulations including Local, State, Federal and/or International requirements.
- Provide direction on submission support, international registrations, and labeling to junior department members.
- Represent Regulatory on core teams providing regulatory feedback and guidance throughout the product development cycle and coordinating team inputs for submissions.
- Prepare global regulatory applications, as well as internal regulatory file documentation.
- Manage submissions such as US FDA Section 510(k) Notifications, Pre-market Approval (PMA) Applications and Supplements, EU IVDD Technical Documentation, and global product registrations.
- Communicate with regulatory agencies on pre-market submissions related activities under the direction of management.
- Document consolidate and maintain oral and written communications with regulatory bodies like FDA, Health Canada, notified bodies, etc.
- Participate in training and education seminars as appropriate to learn regulatory requirements and keep abreast of current regulatory trends.
- Bachelor’s Degree
- Specialization Life Science or Engineering
- Three to five years of pre-market regulatory experience in the medical device industry or equivalent (education and work experience).
- Must have knowledge of U.S, Canadian, European and other International in vitro diagnostic regulations and standards.
- Should have experience working on project/product from concept to market introduction.
- Must have proven analytical capabilities, solid understanding of manufacturing processes, change control, regulatory principles and regulatory trends.
- US-RAC required with less than five years medical device experience. Preferred with greater than five years regulatory experience, but not required.
- Must be able to work well in a team environment with individuals from diverse functional areas, as well as independently manage work.
- Must demonstrate leadership skills in team setting.
- Should have experience in presentation and negotiation of technical issues with internal and external functions including health authorities.
Must be detailed oriented.
- Must possess the ability to represent the Regulatory Affairs department to other departments within the company, and to represent the company to external agencies and organizations.
- Requires ability to speak effectively before groups of customers or employees of organization.
- Requires the ability to organize information to compose reports, documents and presentations. Requires knowledge of scientific, medical and regulatory terms.
- Requires ability to understand and interpret regulatory requirements and technical standards.
- Must have the ability to write and organize complex reports and correspondence to regulatory agencies.
- Requires ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, or governmental regulations.
- Requires ability to edit and proof documents with detailed accuracy.
- Requires ability to effectively present information and respond to questions from groups of managers, clients, customers, regulatory agencies, and the general public.
- Must have ability to calculate dilutions, titrations, and other laboratory methodologies.
- Must be skilled in basic algebra and geometry.
Languages Fluent spoken and written English
- US-RAC required with less than five years medical device experience.
- Preferred with greater than five years regulatory experience, but not required.