Senior Product Compliance Analyst
7 days ago
Location: Plymouth, MN
Schedule: M-F, daytime hours
Compensation: 100k
Benefits: Competitive Benefits package
Travel: minimal
Position
Description:
- The Senior Product Compliance Analyst is focused on product
compliance to regulatory requirements for medical devices in the US, Canada and
in various other countries. This role ensures our products meet all applicable
regulatory standards for safety, efficacy, and quality. The position works
across departments to prepare and submit applications for product approvals,
licenses, and permits, and monitor post-market compliance. They also advise on
regulatory requirements during product development, manufacturing, distribution
and service.
Responsibilities:
- The Senior Product Compliance Analyst will develop US,
Canada and emerging market assessments and submissions for complex projects and
review issues related to regulatory documents, investigations, product
development planning and regulatory agency interaction - The Senior Product Compliance Analyst will assist in
training staff for regulatory requirements as part of the role - Perform facility inspections for compliance to 21CFR820 and
ISO13485 Evoqua policy and procedures assuring compliant operation - Conduct appropriate research using standards, guidance
documents, previous assessments and other resources to develop strong
regulatory assessments for new and modified products - Assume responsibility for project submissions for 510(k)
premarket notifications, Technical File Documentation, and license
submission/amendments - Communicate with management to ensure timely notification of
regulatory changes as appropriate - Work with Quality, Operations, Engineering, and other
internal groups to investigate and recommend solutions to address potential
regulatory issues and impacts - Interact and negotiate with regulatory authorities during
the development (i.e Q-Sub, change notifications, etc.) and submission review - Support regulatory agency and/or notified body audits by as
needed - Participate in development and approval of risk activities
as well as other deliverables as related to medical device projects - Review and approve all Labeling (product, advertising and
promotional) and ensure claims are substantiated - Monitor impact of changing evolving global regulations on
submissions, practices and procedures and communicate to internal stakeholders - Support customer inquiry related to compliance issues
- Comply with Code of Ethics, all Company policies, rules, and
procedures
- Bachelor's degree in a Science or Engineering field, or
equivalent work experience - 5+ years of Medical Device Regulatory Affairs experience,
domestic and international - 3 years of experience with Class II or III medical devices
- Proven history of successful domestic and/or international
submissions - Strong analytical and critical thinking skills
- Strong verbal and writing communication skills
- Ability to manage and prioritize multiple projects to meet
deadlines that align with company
objectives - Proven track record of working as a team player to overcome
obstacles and complete tasks through collaboration - Proficiency in MS Office software programs
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