Sr Manager, Regulatory Affairs
at Thermo Fisher Scientific
Austin, TX 78744, USA -
Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
---|---|---|---|---|---|---|---|
Immediate | 11 Nov, 2024 | USD 177200 Annual | 12 Aug, 2024 | 7 year(s) or above | Strategy Creation,Biology,Medical Devices,High Energy Level,Biologics,Design Control,Continuous Improvement,Chemistry | No | No |
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Description:
JOB DESCRIPTION
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.
LOCATION/DIVISION SPECIFIC INFORMATION
Thermo Fisher is seeking a Regulatory Affairs professional to join the area of molecular diagnostics to lead the Bio-Sciences Division Regulatory Affairs team in North America!
EDUCATION:
- Bachelor degree in Biology, Chemistry, bio-engineering, or related science required.
EXPERIENCE:
- Minimum of 7-10 years Regulatory Affairs experience in Pharmaceutical, Biologics, In vitro diagnostics, or Medical Devices. This experience must include either BLA, 510(k), PMA, CE IVD submissions.
- Well versed in the aspects of regulatory strategy creation, design control, cGMP/quality systems, and import/export requirements.
- Experience as the RA representative on project core teams providing regulatory guidance and RA strategies.
- Managerial competencies in leading impactful teams, demonstrating strong decision-making skills, and the ability to prioritize and deliver on multiple projects simultaneously.
KNOWLEDGE, SKILLS, ABILITIES:
- High energy level; positive attitude; works well under stress, Strong communicator and leader. Hands-on, willing to take action, and able to implement effectively through their team.
- Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency.
- Ability to provide solutions based on knowledge of regulation and experience.
- Willingness to travel (~10-15%).
Responsibilities:
Please refer the Job description for details
REQUIREMENT SUMMARY
Min:7.0Max:10.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Biology chemistry bio-engineering or related science required
Proficient
1
Austin, TX 78744, USA