Similar Jobs
See allSr Manager, Regulatory Affairs
Merative
Regulatory Affairs
Cybersecurity
Team Leadership
Senior Strategic Medical Writer
Abbvie
US
Medical Writing
Clinical Research
Regulatory Submissions
Director, Quality Systems & Regulatory Affairs
CEFALY Technology
US
Quality Management
Regulatory Affairs
Clinical Trial Manager
Oura
US
Clinical Trial Management
Sr. Director, Clinical Data Management
Akero Therapeutics
US
Clinical Data Management
Vendor Management
Regulatory Compliance
Key Responsibilities:
- Develop global clinical strategies to support clinical evidence requirements for product submissions.
- Advance clinical data integrity using software to appraise, analyze, and evaluate clinical data.
- Serve as first author and generate interim and final clinical reports.
Qualifications:
- Degree in Science, Engineering, Health Science, Nursing, or related field.
- 5+ years of professional experience or 10+ years if no degree.
- Experience with medical device or pharmaceutical industry, including US and international regulatory submissions.
What Sets You Apart:
- In-depth knowledge of medical device regulations like MDR, 21 CFR Part 812, and MEDDEV 2.7.1.
- Strong leadership skills with demonstrated ability to drive positive results.
- Experience working with ERP systems, Minitab, and Excel.
Integer Holdings Corporation
Integer is a global organization providing innovative, high-quality technologies and manufacturing to Medical Device OEMs to enhance patients' lives, and supplies high-end niche batteries for specialized markets. We are guided by six Values: Customer, Innovation, Collaboration, Inclusion, Candor, and Integrity, fostering a culture of passionate excellence within our team of over 10,000 employees.