Req ID 56206BR
Regulatory Affairs Specialist
Location of Position
Round Lake, IL
- Coordinate routine change control / manufacturing support for all devices within the Medical Products Division for regulatory assessments to ensure no business / manufacturing interruption
- Compile and submit, in a timely manner, CMC regulatory documents according to regulatory requirements
- Prepare, review, and approve SOPs as assigned
- Participate as an active team member and provide regulatory advice to project teams as required (Example: DHF remediation)
- Maintain regulatory files in a format consistent with requirements
- Develop regulatory strategies as required; identify deliverables needed, co-ordinate with the business and technical and manufacturing groups to create the 510(k) content for identified products as part of the ongoing cumulative review process:
- Represent Regulatory Affairs in project teams
- Evaluate existing product files for compliance to regulations,(Example: identify the need for a submission per the FDA’s draft guidance on “when to submit a 510(k) for changes to marketed products” on an ongoing / annual basis).
Doing Work that Matters
- Written and Verbal communication skills
- Knowledge of regulations
- Negotiation skills
- Technical system skills (e.g. word processing, spreadsheets, databases, online research)
- Manage multiple projects and deadlines
- Ability to identify compliance risks and escalate when necessary Education and / or Experience
- Bachelor’s degree in engineering or related scientific discipline with a minimum of 2 years regulatory or equivalent regulatory experience
- Excellent written and oral English skills required. Additional language skills is an advantage.
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.careers.baxter.com/. EOE M/F/D/V.
Baxter - 2 years ago
axter International Inc. (NYSE: BAX), is an American health care company with headquarters in Deerfield, Illinois. The company primarily...