Olympus Corporation of the Americas
Program Manager, Regulatory Affairs - Remote
6 days agoWhat's your preference?
Job Description
- Req#: 9745
Employer Industry: Medical Technology
Why consider this job opportunity:
- Salary up to $145,685.00 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
- Paid parental leave and adoption assistance available
- Opportunities for career advancement and professional development through dedicated training resources
- Flexible work environment with options for onsite, hybrid, and field work
What to Expect (Job Responsibilities):
- Assist the Manager, Regulatory Affairs in obtaining marketing approval for Olympus medical devices
- Facilitate the development of regulatory strategies for novel technologies and market segments
- Review and approve product labeling and coordinate with marketing and regulatory teams
- Prepare and maintain medical device submissions for the US and international markets
- Stay updated on regulatory changes and advise management on compliance matters
What is Required (Qualifications):
- BS/BA required, preferably in engineering or life sciences; RAC accreditation or post-graduate degree preferred
- Minimum of 10 years of regulatory affairs experience in the Medical Device industry with a BS/BA, or 7 years with a Master's degree
- Mandatory experience in writing US and EU submissions and direct collaboration with regulatory authorities
How to Stand Out (Preferred Qualifications):
- Experience in regulatory affairs within a global medical technology environment
- Familiarity with Canadian regulatory submissions for Class 2, 3, or 4 devices
- Proven ability to interface with international regulatory teams for product registration
#MedicalTechnology #RegulatoryAffairs #CareerOpportunity #CompetitivePay #ProfessionalDevelopment
We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.About the company
Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000.
Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.
An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report. NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.