Located in Austin, Texas! We are a well-established, fast-growing, medium size medical device company specializing in devices for cryopreservation and cell culture. We are currently looking for an experienced Regulatory Affairs Director to join our team.
The Regulatory Affairs Director is responsible ensuring compliance with global medical device regulations including CFR, ISO 13485 and MDSAP requirements. This position will manage both the Regulatory and QA staff.
Essential Duties and Responsibilities
The essential duties and responsibilities of this position include, but are not limited to the following:
Develops a forward-looking compliance program to maintain global distribution of medical devices.
Advocate for and work within a medium size device firm.
Ensures that the Quality System requirements are established and maintained as described in applicable FDA and International Standards.
Provide clear and concise reporting on QA and RA functions.
Technical writing, direction and submission of Regulatory documentation.
Manage and improve the Quality function through direct report supervisors.
Oversees Quality Assurance functions, including
All internal and external audits
CAPA, complaints and MRBs
Maintains and updates Technical Files on company’s devices.
Works with other departments to integrate Regulatory and Quality requirements into all processes.
Assists our Distributors in meeting local regulatory requirements.
Leads their team to achieve deadlines on time and on budget.
Participates in all phases of Product Design.
Participates in Strategic Planning.
Proven Leadership Skills
Intimate knowledge of Regulatory environment for medical devices, CFR, 13485. MDR
Cost conscious, small company attitude
Excellent communication and interpersonal skills
Superior organizational and time management skills
Sound decision making
Close attention to detail
Broad creativity and curiosity
Effective problem-solving skills
Adaptability, can work with changing priorities
Minimum Qualifications (Knowledge, Skills, and Abilities)
Bachelor’s degree in Science/Math/Engineering
10+ years’ experience in QA / RA in medical device manufacturing
5+ years of leadership experience
4+ years’ recent experience in CFR / ISO 13485 environment
Audit experience with FDA and Notified Bodies
Ability to understand and interpret customer needs; ability to work with all work functions (i.e. Regulatory, Operations, Human Resources, Engineering)
Ability to work independently and lead in a team environment
Masters’ degree in a related discipline
Professional certification preferred (ASQ CQA, CQE, C Q. Mgr, CQA-Biomedical, RAC)
This position has direct supervision. The individual may also be required to lead project teams and ensure participants meet deadlines.
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. This job often operates in a cleanroom environment. Cleanroom environment requires personnel to wear personal clothing completely covering the legs; company-provided cleanroom coat, bouffant, face mask, and gloves.
Physical Demands and Work Environment
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential job duties and responsibilities of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions.
While performing the duties of this position, the employee is regularly required to talk and hear. The employee is frequently required to use hands, fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand; walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, and the ability to adjust focus. The noise level in the office environment is usually minimal.
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About OriGen Biomedical Inc
OriGen Biomedical, Inc. is a leading producer of cryopreservation, cell culture, and ECMO respiratory products. OriGen’s focus is to produce a range of products to support the treatment of respiratory distress, cancer, genetic conditions, and other life threatening diseases. Our products are designed with the patient and user in mind and we strive to maintain excellent customer service to ensure that patient care is the priority.OriGen’s Cryopreservation line includes the CryoStore EVA freezing bag, CryoStore Conical Freezing Bag, CryoStore Multi-Chamber Freezing Bag, O-Wrap overwrap bags, SteriZip Overpouch, CryoPur DMSO Solutions, CryoBag, Tissue Vault, and a variety of accessories for every customer’s need.OriGen’s Cell Culture line includes the PermaLife FEP cell culture and freezing bag, the Evolve EVO cell culture bag, and a variety of accessories.Product quality is the foundation of all product designs at OriGen, and each product is produced with the intention that it will improve patient health. OriGen is certified annually to ISO13485 standards, and regularly inspected by the FDA, ISO-certification organizations, and our customers.