Our client, a foremost leader in biotechnology with over $15 billion in sales revenue and 50,000 employees world-wide wants your talent and expertise on their team!
We are seeking an experienced Regulatory Affair Specialist III to join the Global Regulatory Department in the exciting area of in-vitro diagnostics for their location in Austin, TX. This position reports to the Director or Senior Manager of Regulatory Affairs. The qualified candidate will provide strategic support to fundamental teams supporting new and innovative preparation technology. Our client offers a competitive base salary, an attractive bonus plan and an exciting career track.
If you have a bachelor’s degree in Biology, Chemistry, Bio-engineering or related science and preferably a minimum of 4 years within a technical environment; Regulatory Affairs, Quality Assurance, Software/System engineering, or research and development, please submit your resume in Word format to [email protected].
Relocation assistance will be provided.
Responsibilities:
- Assist with sample preparation technologies used with PCR and capillary electrophoresis
- Create and maintain Device Master File (MAF), draft and review 510ks and assist on-site audit and publishing regulatory activities
- Review advertising and promotional materials on Class I and II IVD and RUO products
- Provide filing submission support by collecting information and preparing documentation for submission to regulatory agencies or outside partners, if required
- Review product labeling, advertising/marketing material for legitimacy and compliance to regulatory requirements
- Provide strategic regulatory guidance and support to new and existing project teams and external business partners
- Participate in project activities and review key project documents (i.e., product design protocols related to verification and validation, risk assessment)
- When needed, support in 510(k) and EUA submissions
- May be asked to provide regulatory assessment of the on-market product changes and perform regulatory filing submission support
- Oversee the preparation of ex-US registrations and communicate with Regulatory Affairs associates outside the United States to confirm actions are provided in the correct timeline to support existing IVD products
- Maintain current knowledge of new or changed regulations, guidelines, compliance guides, inspection reports, journals, meetings, etc.
- Assist in the update, enhancement, and creation of internal policies and procedures
Qualifications:
- A minimum of 4 years within a technical environment preferably in Regulatory Affairs, Quality Assurance or Software/System Engineering
- A bachelor’s degree in Biology, Chemistry, Bio-engineering or related science
- Knowledge in the aspects of regulatory submissions, design control and cGMP/Quality Systems is required
- Possess and display an in-depth understanding of advanced technical and scientific principles in relation to IVD reagent chemistry, laboratory automation and software components of IVD medical devices
- Effectively communicate regulations to technical administrators within the company
- Possess a dynamic and positive attitude with the ability to work effectively under pressure
- Strong communication and leadership skills
- A hands-on and goal-oriented leader who can effectively implement successful team growth
- Possess continuous improvement minded skills and can balance both the need for quality and the need for efficiency
- Capable of working independently in a matrix-managed environment
- Can effectively work through periods of transition and adjustment
- Ability to travel 10% -15 % of the time