Job Description
Job Description
- Emerging Regulations team- manages regulations and works with cross function teams.
- Regulations can be very narrow and specific.
- Analytical, proactive, communication skills, must do research and prep work to understand regulations before meetings with stakeholders.
- Some documentation work - identify gaps in processes or product design.
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- Review / approval of engineering study protocols / reports and validation study protocols / reports.
- Review and assessment of emerging regulations.
- Recent experience with medical devices design controls; understanding of engineering change control process, familiarity with Agile PLM system
- May require an advanced degree and 2-4 years of direct experience in the field.
- Relies on analytical thinking and judgment to plan and accomplish goals.
- Performs a variety of tasks. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit / department.
- Please look for associates who have background not just in Regulatory Affairs but also from engineering, quality, and manufacturing, who are willing to look for a career in Regulatory Affairs.
- Interviews : 1 interview with hiring manager and then interview with manager's leadership
Company Description
Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data / AI.
With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
Company Description
Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data / AI.
With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
Associate Director, Regulatory Affairs
The Associate Director, Regulatory Affairs at 4DMT, will be focusing on managing CMC, pre-clinical, and clinical regulatory applications (domestic and international) in support of 4DMT’s multiple therapeutics in development. Establish the long-term strategy for the regulatory team and regulatory act...
Regulatory Affairs Associate
Please look for associates who have background not just in Regulatory Affairs but also from engineering, quality, and manufacturing, who are willing to look for a career in Regulatory Affairs. ...
Associate Director Regulatory Affairs – APAC - Diabetes Care (on-site)
As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Associate Director Regulatory Affairs – A...
Associate Director, Regulatory Affairs
Innova Solutions is immediately hiring for an Associate Director, Regulatory Affairs. Associate Director, Regulatory Affairs , you. In collaboration with Regulatory Affairs functional management, coordinate the provision of resources from the various Regulatory functions in support of clinical studi...
Senior Associate, Regulatory Affairs
The Senior Associate will support all aspects of regulatory affairs related to the development of novel CAR T therapies including quality, preclinical and clinical areas of drug development. Interest in building a career in Regulatory Affairs. Assist in the authoring, submission, and maintenance of ...
Associate Director, Regulatory Affairs
Innova Solutions is immediately hiring for an Associate Director, Regulatory Affairs. Associate Director, Regulatory Affairs , you. In collaboration with Regulatory Affairs functional management, coordinate the provision of resources from the various Regulatory functions in support of clinical studi...
Regulatory Affairs Associate
Manage portfolio timelines in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions calendar. Review clinical site regulatory documents to provide Regulatory approval to ship investigational product. Assist Project Team Regulatory...
Senior Associate, Regulatory Affairs
About the role:The Senior Associate will support all aspects of regulatory affairs related to the development of novel CAR T therapies including quality, preclinical and clinical areas of drug development. Interest in building a career in Regulatory Affairs. Responsibilities include:• Assist in the ...
Associate Director, Regulatory Affairs
We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders his...
Regulatory Science Program Faculty Director - Assistant, Associate, or Full Professor
Regulatory Science Program Faculty Director - Assistant, Associate, or Full Professor. Depending on qualifications, applicants may be appointed at any of the levels of these series, assistant, associate or full. The successful candidate will serve as the faculty director for a new Master's program i...