- Serve as an experienced regulatory compliance advisor and authority on key strategic and critical compliance issues. Provide guidance to product line compliance engineers, product managers and engineering staff.
- Lead Problem solving activities (independently and as a team) on critical Product safety/Regulatory compliance investigations.
- Stay current on applicable Standards and Regulations and communicate these across the organization as required, including advising how they impact Analogic’s products and costs.
- Oversee processes to ensure compliance work is done efficiently, meeting published timelines, milestones and budgets.
- Support New Product Development (NPD) and Sustaining teams to develop and execute testing as required for maintaining regulatory compliance.
- Manage all required reporting to agencies for Analogic’s existing products, to maintain compliance in the various countries that may require renewals.
- Follow all Regulatory submittals through complete process to ensure approvals are received in time for planned production.
- Prepare appropriate documentation and sample submission packages. Initiate and manage NRTL (National Recognized Test Laboratory) projects. Examples of NRTL’s include UL, CSA, TUV and more.
- BS degree in a technical discipline, and 7-10 years of direct experience leading various aspects of global Safety Regulatory and Compliance processes.
- Knowledge of regulatory requirements/product safety certification processes e.g., NTRL / UL standards and testing requirements.
- Knowledge of product CE Mark and declarations needed, FDA filing experience a plus.
- Knowledge of AGILE PLM a plus.
- Ability to perform in a multifunctional-team-work environment and be able to work independently
- Skills to work well with regulators regarding including inspection activities/outcomes, field actions, and other compliance issues.
- Strong analytical skills and experience implementing risk-based oversight programs.
- Strong Excel/Spreadsheet analytical skills
- 9/80 work schedule – enjoy every other Friday off!
- Flexible Vacation – employees can take time off as is reasonably needed
- Comprehensive benefits including medical, dental, vision, life insurance and disability plans.
- HRA (for PPO plan participants) /HSA (Health Savings Account for high deductible plan participants) contribution
- 401K with company match and immediate vesting
- Continuous Education Assistance
- Supportive culture that values innovation, collaboration, and excellence
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Skills Required
- BS degree in a technical discipline
- 7-10 years of direct experience in global Safety Regulatory and Compliance processes
- Knowledge of regulatory requirements and product safety certification processes
- Knowledge of product CE Mark and declarations, FDA filing experience a plus
- Knowledge of AGILE PLM
What We Do
Analogic provides leading-edge healthcare and security technology solutions to advance the practice of medicine and save lives. We are recognized around the world for advanced imaging systems and technology that enable computed tomography, digital mammography, and magnetic resonance imaging (MRI), as well as automated threat detection for aviation security. Analogic’s aviation security solutions, such as our ConneCT checkpoint security scanner, are designed to meet the highest standards for threat detection and are operational at airports worldwide. Our CT, MRI, and digital mammography products are sold to original equipment manufacturers (OEMs), providing state-of-the-art capability and enabling them to enter new markets and expand their existing market presence. Today, Analogic's subsystems are used in approximately half of the world's CT and MRI scanners. For over 50 years we've enabled customers to thrive, improving the health and enhancing the safety of people around the world. Analogic is headquartered just north of Boston, Massachusetts. For more information, visit www.analogic.com.
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