Olympus Corporation of the Americas
Program Manager, Regulatory Affairs - Remote
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Job Description
- Req#: 9738
Employer Industry: Medical Technology
Why consider this job opportunity:
- Salary up to $167,538 per year, plus potential for annual bonus
- Comprehensive medical, dental, and vision coverage effective on start date
- Generous paid vacation and sick time, along with 12 paid holidays
- Opportunities for paid educational assistance and professional development
- Flexible work environment with onsite, hybrid, and field work options
- Supportive culture with employee resource groups and wellness programs
What to Expect (Job Responsibilities):
- Assist in developing regulatory strategies for new medical technologies and market segments
- Review and approve product labeling and coordinate with marketing and regulatory teams
- Prepare and maintain US medical device submissions, including Pre-Submissions and 510(k)s
- Lead responses to regulatory authorities’ requests for additional information
- Maintain regulatory files and tracking databases to ensure accurate access to regulatory information
What is Required (Qualifications):
- Minimum of 10 years of regulatory affairs experience in the medical device industry with a BS/BA, or 7 years with an MS
- Proven experience in writing US and EU submissions and collaborating with regulatory authorities
- Bachelor’s degree required, preferably in engineering or life sciences
- Strong understanding of worldwide regulatory requirements related to medical devices
- Experience in developing and maintaining regulatory files and databases
How to Stand Out (Preferred Qualifications):
- RAC accreditation or a postgraduate degree in a relevant field
- Experience in interfacing with international regulatory teams for market registrations
- Demonstrated ability to advise on regulatory initiatives and changes within the organization
- Knowledge of Canadian and international medical device submission processes
- Familiarity with new product development and market strategies
#MedicalTechnology #RegulatoryAffairs #CareerOpportunity #CompetitivePay #ProfessionalDevelopment
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