Senior Manager Internal Audit & GRC at Birlasoft, developing audit plans and leading internal audits. Collaborating with leadership to mitigate risks and enhance controls across the organization.
About the role
- Regulatory Affairs Specialist supporting regulatory activities for medical devices at RefleXion. Collaborating with teams to ensure products meet global regulatory requirements and compliance.
Responsibilities
- Contribute to the preparation and support of regulatory submissions and filings for U.S. FDA and other global regulatory bodies (e.g., Notified Bodies for CE marking, Health Canada).
- Assess and document product changes for regulatory impact.
- Collect and organize information related to product changes and their impact on global regulatory approvals.
- Support product development teams in implementing international regulatory requirements.
- Assist with maintaining annual licenses, registrations, and regulatory listings to ensure continued compliance.
- Support adverse event reporting to regulatory agencies and internal stakeholders.
- Monitor changes in regulations and standards and communicate impacts to internal teams.
- Maintain and update regulatory affairs procedures using established change control processes.
- Maintain and track applicable external regulatory standards.
- Support continuous improvement of regulatory submission processes.
- Perform other related duties as assigned.
Requirements
- Bachelor’s degree in a scientific discipline; advanced degree preferred.
- Approximately two (2) years of experience in medical devices or regulatory affairs.
- Experience with electromechanical and/or software-driven medical devices preferred.
- Familiarity with software development as it relates to regulatory submissions is a plus.
- Strong computer skills, including Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
- Excellent attention to detail, organizational, and documentation skills.
- Strong written and verbal communication skills.
- Ability to work independently as well as collaboratively in a team environment.
- Ability to work on-site in Hayward, CA at least part-time during the contract period.
Benefits
- Health insurance (both HMO and PPO options) with Health Savings Account (HSA) option
- Paid Company Holidays and Paid Sick Time
- RefleXion Benefit Hub – Company exclusive discounts and deals on a variety of sites and items
- Weekly catered on-site lunches as well as kitchens filled with a variety of healthy and delicious food and drinks – including an espresso machine and panini stations!
- Employee Events – Variety of Lunch ‘n Learns, Financial Wellness education, Regular “Coffee Chats” with Executive Leadership, Scavenger Hunts, Company Milestone celebrations and more!
- Electric car charging stations on site
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