Job Description:

Responsible for assisting the RA Head in managing all facets of regulatory support to market S3V Vascular products. This includes developing regulatory submissions, managing departmental projects, creating and reviewing labelling, providing guidance and consultation for domestic and international regulations, interacting with governmental agencies and managing a staff of regulatory professionals.

Responsibilities:

- Manages systems for assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the USFDA regulatory submissions process.

- May author and publish electronic submissions -

- Manages the development of dossiers for registration of products in countries outside India.

- Oversees the authorship and publication of electronic submissions - Assigns RA Professionals (Executives / Trainees) to serve on development project teams as core team members; communicates regulatory strategy for new products -

- Keeps all areas informed of regulatory requirements and emerging issues which may affect the registration approval of products. - Reviews the Dossiers / Technical Files for CE Certifications, 510k Submissions, Submissions to the CDSCO for Import License, Tet License and Registration Certificate etc. - Communicates with Regulatory agencies. -

- Directs and oversees the work of RA professionals (Executives / Trainees), including training, mentoring and insuring professional development. - Maintain timelines for full regulatory documents -

- Interprets and applies USFDA/European/CDSCO regulations to business practices and provides regulatory input, advice and guidance to the organization

- Assists the RA Head in establishing RA policies and procedures and ensures compliance with them -

- Provides regulatory advice and guidance to ensure compliance with appropriate national/regional government regulations and requirements (including review of protocols, drug development plans, study reports, and marketing application components) -

- Coordinate interactions and timelines with outside vendors regarding regulatory documents. -

- Interact with appropriate national/regional government regulatory agencies; and -

- Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

Education and Experience:

- M. Pharm degree with 5-6 years OR Bachelor's degree with 8-10 years regulatory affairs experience in Medical Device Industry - Knowledge of medical device products and regulations and ability to interpret them. -

- Ability to lead a team, influences others, and handles increasing levels of responsibility.

- Ability to build relationships with other areas of the organization (i.e. marketing, research).

- Effective oral and written communication skills

- Knowledge of Computer software applications including Microsoft Office

- Ability to manage/supervise employees -

Results oriented focus

- Ability to work independently and support multiple projects