Regulatory Affairs Specialist, Ops - Johnson & Johnson MedTech, Circulatory Restoration
About The Position
Johnson & Johnson is hiring a Regulatory Affairs Specialist, Ops to join its team in Santa Clara, California. This individual-contributor role supports securing and retaining global regulatory approvals for medical devices by creating, archiving, and maintaining regulatory documentation and data. The role provides regulatory submission publishing and verification support and contributes to Regulatory Infrastructure and Operations functions and projects. The position supports worldwide submissions in accordance with geography-specific requirements, regulatory licenses and registrations, document control, archiving, country-specific regulatory activities, and audit support. The specialist also helps improve departmental processes and procedures and maintains compliance with applicable company policies.
Requirements
- Bachelor's degree or equivalent experience.
- At least 2 years of experience in a regulatory position in a regulated healthcare industry or equivalent.
- High proficiency with Microsoft Word, SharePoint or equivalent, Excel, Adobe, and PowerPoint; proficiency with Word Macros and Styles.
- Strong digital aptitude, including proficiency with digital systems and databases and the ability to learn and navigate new platforms and applications efficiently.
- Flexibility with changing priorities and ability to manage multiple tasks, prioritize, and schedule work to meet business needs and timelines.
- Organized, detail-oriented, with good planning and time-management skills.
- Sound and ethical judgment within company policy and regulations.
- Analytical thinking and good problem-solving skills.
- Clear and effective verbal and written communication skills with various levels of the organization.
- Ability to work collaboratively in a fast-paced environment while concurrently managing multiple priorities and maintaining accuracy.
- Ability to complete short- and long-term projects of moderate complexity with some guidance.
- Apply Johnson & Johnson’s Credo and Leadership imperatives in day-to-day interactions with internal and external colleagues.
Nice To Haves
- Bachelor's degree in science, math, engineering, or medical fields is preferred.
- Notary Public Commission, or willingness to obtain, is an asset.
Responsibilities
- Publish worldwide regulatory submissions in compliance with geography-specific regulatory requirements.
- Track original and renewed annual licenses and registrations/listings, and collect, organize, and disseminate registration renewal documentation when required.
- Archive submissions, correspondence, and other regulatory documentation in a designated document repository using standardized formats and processes.
- Author and route document changes through an electronic document control system.
- Provide country-specific regulatory support.
- Procure document notarizations, authentications, legalizations, and certifications.
- Contribute to continuous improvement of departmental processes and procedures.
- Ensure personal compliance with applicable company policies and procedures.
- Provide audit backroom support.
- Perform other duties as needed.
Benefits
- Retirement plan (pension) and savings plan (401(k)), subject to plan terms.
- Eligibility to participate in the Company's long-term incentive program.
- Vacation: 120 hours per calendar year, subject to policy and hire date.
- Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington, subject to policy and hire date.
- Holiday pay, including floating holidays: 13 days per calendar year.
- Work, Personal and Family Time: up to 40 hours per calendar year.
- Parental Leave: 480 hours within one year of a child's birth, adoption, or foster care placement.
- Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
- Caregiver Leave: 80 hours in a 52-week rolling period.
- Volunteer Leave: 32 hours per calendar year.
- Military Spouse Time-Off: 80 hours per calendar year.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
