The employees at Hemanext are committed to continuing the effort of the transfusion medicine community to save lives and improve patient outcomes. Our distinctive focus is on innovations systems enabling blood collection, processing, storage and transfusion that will promote radical improvement in the quality, safety, efficacy and cost of transfusion therapies.
The Sr. Director will manage and provide strategic leadership for global regulatory strategy, agency interactions, and submissions. He/she will be responsible for devising and implementing regulatory strategy and providing leadership oversight for all regulatory submissions, regulatory compliance, regulatory advice and counseling in all areas (pre-clinical through commercial). The position will provide leadership for all regulatory activities to drive product development programs and ensure the Company’s ongoing compliance with regulatory mandates.
The Sr. Director will provide management and overall strategic direction and operational ownership of the Quality Management System and will ensure compliance with all applicable regulatory requirements and alignment with Hemanext’s objectives and Quality Standards. He/she will be responsible for ensuring that the company’s Quality Systems enable and facilitate compliance in a phase-appropriate manner (pre-clinical through commercial) and will oversee all aspects of the QMS such as inspection and audit management, Complaints, Documentation, CAPA, Change control, training, QMRs, as well as supplier management and ensuring data integrity.
About the Role…
Reporting to the Vice President of Commercial Operations, the Senior Director of Regulatory and Quality Affairs (RA/QA) will have overall responsibility for ensuring ….
- Hemanext Quality system requirements are effectively established, implemented and maintained in compliance with cGMPs, ISO and other regulatory requirements.
- Direct quality personnel in the establishment, training, implementation, and monitoring of quality procedures.
- Facilitate all external customer matters relating to Hemanext quality system.
- Develop Quality System procedures to enhance overall Quality performance and compliance.
- Host all medical device related site audits. Document audit results and communicate to management responsible for the sites.
- Conduct internal quality audits at regular intervals to assure that the Quality System is in compliance with the established Quality System requirements to determine the effectiveness of the Quality System and report to executive management on their effectiveness.
- Participate in the coordination, review, investigation and documenting of complaints relating to possible medical device reporting as required by the applicable, FDA, ISO and EN quality system requirements.
- Chair Quality System Management meetings.
- Hemanext products adhere to all regulatory requirements and clearances in the US, Europe, and the rest of the world (RoW).
- Ensure Hemanext sites comply with all related aspects of regulatory agency compliance. Develop and implement global regulatory strategies for medical device products from development through marketing approval for the US and EU markets.
- Responsible for Regulatory leadership in directing personnel to develop and submit product submissions for the US, Europe, and the rest of the world (RoW) to obtain 510(k) approval, CE mark, and other new product regulatory approvals.
- Develop strategies and tactics to obtain FDA and international regulatory approvals of marketing applications and clinical trial applications in the US and around the world.
- Review and approve changes to manufacturing processes and products, obtain and maintain certification to ISO 13485 and FDA site registration.
- Direct clinical personnel in the clinical product requirements for each product developed and the development of clinical study protocols and related documentation.
- Hemanext clinical and human factors requirements supporting global regulatory filings for products are fulfilled.
- Hemanext’s QA/RA capabilities and qualifications enable critical strategic initiatives.
- Serve as Management Representative and, as such, is responsible for and has the authority that includes:
- Ensure processes needed for the quality management system are established, implemented, and maintained.
- Report to executive management on the performance of the quality management system and any need for improvement.
- Ensure the promotion of awareness of regulatory and customer requirements through-out the organization.
- Participate in FDA and notified body audits for MDR, MDSAP, and QSR and BIMO compliance.
- Serve as Compliance Officer
- Manage and ensure compliance policies and protocols are in place and followed – ensure organization is trained and operating in accordance to governing laws.
- Determine compliance metrics and establish a system for tracking.
- Represent QA/RA on any marketing and advertising collateral to ensure compliance.
About Your Work Experience….
- 10+ years’ experience in Quality and/or Regulatory Affairs.
- 5-10 years supervisory and management experience with solid people management experience including the build of a high-performance team highly desired. Experience coaching, training and performance managing professional teams and working with Executive and management teams.
- Experience in the medical device field required.
- Ability to travel periodically as required.
- Track record of successful regulatory filings on a global basis a plus.
About your education and competencies….
- BS or BA in a biomedical science, engineering or medical technology; Masters degree preferred.
- QA/RA training, certifications and industry recognized qualifications preferred.
- Experience with Class II medical devices required.
- Experience with EU MDD/MDR required. Understanding of European regulatory approaches is advantageous.
- Solid experience and proven track record in successful international and FDA submissions required.
- Excellent interpersonal skills with demonstrate excellence in written and verbal communication.
What Hemanext offers you…
Hemanext is a pre-revenue company founded on a decade of scientific research and innovation and dedicated to bringing advancements in the world of transfusion therapy, and by doing so, dramatically impacting the patient’s quality of life. We want to create what has never been done before for some of our sickest patients.
You will be working alongside some of the brightest, most creative and patient-focused people you will have ever worked with. We are looking for employees who have a passion and hunger to use their educational and professional experiences to achieve our mission. The stakes are high, and we are working a green field of opportunity to bring about seismic change.
If this appeals to you, we also offer comprehensive Health-care benefits including Medical, Dental and Vision insurance, Stock Options, a 401K retirement plan, Life and disability insurance along with, 3 weeks’ vacation to start and an on-site gym!
You must be able to provide proof of authorization to work in the United States as a condition of employment.
Hemanext s a smoke-free, alcohol-free and drug-free work environment. Hemanext is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Hemanext will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
To Apply → Please send your resume to firstname.lastname@example.org or apply through Linkedin.com.