Atossa Genetics is a women’s healthcare company specializing in the development of proprietary medical devices and laboratory services to stratify, assess, profile, and monitor the breast health in patients.
We accept enthusiastic, high quality undergraduate or graduate students interested in learning the industry as interns. Stipend may be awarded depending on the skills and experiences. Please send your resume and contact information for two references to firstname.lastname@example.org.
SENIOR MANAGER, DEVICE QUALITY ASSURANCE AND REGULATORY AFFAIRS
The Senior Manager, Device QA/RA is accountable for the effective management of all regulatory activities associated with the development, registration and maintenance of assigned Atossa Genetics medical devices worldwide. This position manages the process of fulfilling regulatory requirements associated with the product quality (e.g., 21 CFR 820 QSR) and marketing approval of new products and continued support of marketed products. The Senior Manager works independently with consultation by Regulatory Management on regulatory and quality strategy for research, transition and development projects in order to shorten time to FDA approval and obtain the most favorable outcome, and provides timely updates on all projects to Senior Vice President, Global RA/QA. The Senior Manager works on complex regulatory and quality issues in which analysis requires an in-depth evaluation of various factors, and regularly interacts with internal cross-functional teams as well as CROs and CMOs to provide guidance and solutions for difficult regulatory and quality situations and issues.
In addition, the Senior Manager is responsible for the regulatory submission and the review and implementation of departmental systems for regulatory submissions and safety reporting. The Senior Manager may be supported by Senior Vice President, Global RA/QA, who assists in designing standard requirements for submissions (e.g. 510 (k), PMA, CE mark, etc.) and preparation of relevant procedures describing responsibilities and processes for the regulatory affairs department.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Provides recommendations to Project Team or ad hoc committees with consultation by Senior Vice President, Global RA/QA on regulatory and quality direction for development projects and approved products to be incorporated into the development strategy. Recommendations are based on knowledge gained from direct FDA experience, previous submissions and FDA Advisory Committee meetings.
- Provides regulatory and quality advice and consultation for products within their responsibility to Senior Management for incorporation into the decision making process.
- Establishes and maintains regular and effective interface with FDA officials to acquire a knowledge base of regulatory and quality requirements and strategy to enable Atossa Genetics to efficiently and effectively shorten development and FDA approval times.
- Prepares submissions of registration documents (510 (k), PMA, CE mark, etc.) with consultation by Regulatory Management.
- Reviews material for completeness, internal consistency with other documents, conformance to FDA regulations; assures readiness for submission by gathering missing information, resolving internal consistency and regulatory issues; compiles high quality submissions that are fileable and meet all FDA requirements.
- Writes meeting minutes of meetings/teleconferences with FDA are clearly understood and agreed upon by all participants and communicated to appropriate individuals within one week.
- Assures that all interactions (verbal or written) with regulatory authorities reflect credible regulatory and corporate reputation.
- Develops a reporting system for presenting Management review quality metrics reports to Senior Management.
- Develops Quality systems standard operating procedures and maintains the current Quality systems SOPs
- Works with CMOs to monitor projects in terms of quality metrics system with tracking and trending.
- Provides hands on support for the Design Control system, Device Master File, Device History File and provides direction to other departments.
- Assists with the material and lot disposition for material with non-conformances.
- Revises, develops and maintains Quality Systems standard operating procedures (SOPs) for Device Changes, Deviations, Quarterly and annual product reporting.
- Assists in the training programs for effective Quality systems SOPs to employees.
- Works with the Senior Vice President, Global RA and QA to develop standardized procedures for the preparation of regulatory submissions to assure consistency within and between various Centers at FDA and other regulatory agencies.
- Collaborates with Regulatory Operations staff to assure timely completion of paper and electronic submissions for the Regulatory Affairs department.
- Prioritizes assignments to meet corporate timelines.
- At the request of Business Development, reviews and provides evaluation of the regulatory implications of licensing and acquisition candidates to make appropriate business decisions.
- Identifies and clearly communicates all regulatory issues related to projects to Regulatory Management.
- Assists Senior Vice President, Global RA and QA with department budget.
- Maintains strong cross-functional communications with internal cross-functional teams and CMOs. This requires providing regular QA update reports, timely communications regarding resource concerns, and prompt notice of QA issues that impact the regulatory compliance as a whole.
- Collaborates effectively with members of the various project teams and other employee groups.
Education, Experience and/or Skills Required
- BS degree in Science or Engineering or equivalent. Advanced degree a plus.
- 10+ years’ experience in the medical device/biopharmaceutical industry.
- 7+ years’ experience in Regulatory Affairs.
- Requires the ability to change the thinking of or gain acceptance of others in sensitive situations.
- Ability to communicate effectively orally and in writing to maintain effective links with QA management, contract manufacturers, contract employees and project team members.
- Strong interpersonal and communications skills, collaboration/teamwork, and adaptive skills required.
- Highly organized.
- Capable of supporting numerous projects simultaneously.
- Able to travel approximately 20%.
To apply for this position please send your resume to email@example.com.
If you are interested in employment at Atossa Genetics:
Please send your resume and the contact information of two references to firstname.lastname@example.org or send an email for more information.