| Company: | GenQuest BioScience, Inc. |
|---|---|
| Type: | Full Time |
| City: | Mountain View |
The Manager or Director of Regulatory and Clinical Affairs is responsible for developing innovative, actionable strategies that will help company bring its technologies to the advanced interventional endoscopy community throughout the world. The Manager or Director of Regulatory and Clinical Affairs will work with and be part of the corporate team that manages and implements regulatory strategies to meet corporate objectives. This position will have high visibility within the organization and will collaborate with multifunctional teams.
The Manager or Director of Regulatory and Clinical Affairs will be responsible for tasks and deliverables that are integral to corporate strategy, including: Operating effectively in a small company team setting and is committed to achieving both regulatory and company goals. Managing the preparation and filing of all regulatory documents with the FDA and international regulatory agencies. Maintaining up to date knowledge and understanding of regulatory requirements and concerns that affect company and communicate changes to relevant personnel. Interacting on a regular basis with corporate leadership team to ensure that business objectives are aligned and that company is performing to agreed-upon goals. Representing company with regulatory bodies and IRBs and medical professionals involved in clinical research with the company. Leading the design and execution of US and OUS clinical studies, including protocol development, study implementation, and data management. Developing in depth knowledge of clinical issues related to achievement of clinical and marketing objectives. Develop and foster strong relationships with key opinion leaders in interventional endoscopy.
Qualifications include: A minimum of 5-8 years of combined regulatory and clinical affairs experience within medical device companies. Demonstrated success in obtaining FDA clearance for products/technology and, in particular, in filing 510(k) submissions. Proven ability to troubleshoot within FDA and international regulations and guidelines including clinical strategy, GCPs, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting. A history of effective collaboration with the FDA and other regulatory bodies. Strong written, verbal and presentation skills, including accomplished public speaking skills with the ability to present, persuade and convince regulators, investors and key opinion leaders with respect to company products and clinical/regulatory strategies. Small company, “hands-on” experience. Evidence of leadership and a management style characterized by vision, teamwork, preparation, communication and negotiation. Successful management of relationships at all levels of the organization. Ability to prioritize, juggle multiple projects and meet deadlines, both as an individual contributor and support team member. Familiarity with gastroenterology or endoscopy is a plus. Up to 25% travel.
How to Apply:
Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: jobs@genquestbio.com
To learn more about this position or to preview other opportunities, please visit our website at:
www.genquestbio.com/careers.htm
The Manager or Director of Regulatory and Clinical Affairs will be responsible for tasks and deliverables that are integral to corporate strategy, including: Operating effectively in a small company team setting and is committed to achieving both regulatory and company goals. Managing the preparation and filing of all regulatory documents with the FDA and international regulatory agencies. Maintaining up to date knowledge and understanding of regulatory requirements and concerns that affect company and communicate changes to relevant personnel. Interacting on a regular basis with corporate leadership team to ensure that business objectives are aligned and that company is performing to agreed-upon goals. Representing company with regulatory bodies and IRBs and medical professionals involved in clinical research with the company. Leading the design and execution of US and OUS clinical studies, including protocol development, study implementation, and data management. Developing in depth knowledge of clinical issues related to achievement of clinical and marketing objectives. Develop and foster strong relationships with key opinion leaders in interventional endoscopy.
Qualifications include: A minimum of 5-8 years of combined regulatory and clinical affairs experience within medical device companies. Demonstrated success in obtaining FDA clearance for products/technology and, in particular, in filing 510(k) submissions. Proven ability to troubleshoot within FDA and international regulations and guidelines including clinical strategy, GCPs, GLPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting. A history of effective collaboration with the FDA and other regulatory bodies. Strong written, verbal and presentation skills, including accomplished public speaking skills with the ability to present, persuade and convince regulators, investors and key opinion leaders with respect to company products and clinical/regulatory strategies. Small company, “hands-on” experience. Evidence of leadership and a management style characterized by vision, teamwork, preparation, communication and negotiation. Successful management of relationships at all levels of the organization. Ability to prioritize, juggle multiple projects and meet deadlines, both as an individual contributor and support team member. Familiarity with gastroenterology or endoscopy is a plus. Up to 25% travel.
How to Apply:
Resumes must be sent via e-mail only and as a file attachment in either MS Word or Rich Text format to: jobs@genquestbio.com
To learn more about this position or to preview other opportunities, please visit our website at:
www.genquestbio.com/careers.htm
