Job Description
REGULATORY AND QUALITY SYSTEMS
- Manages and develops Regulatory Affairs and identified Quality Systems personnel.
- Develops and revises, as necessary Quality Management System policies, procedures, work instructions and other documentation to support an effective, efficient, and sustainable QMS.
- Monitors the health of the Quality Management System to identify areas of weakness and coordinate activities to improve regulatory or quality system compliance including, but not limited to 21CFR Part 820, Part 803, 21 CFR Part 7 and EU MDR 2017/745.
- Manage, coordinate, and provide updates for quality, regulatory metrics, and post market surveillance trending. Trend and escalate issues to the Quality Management Representative and or the Person Responsible for Regulatory Compliance
- Works with the Management Representative to coordinate, prepare, and execute company Management Reviews.
- Acts as site point of contact for external audits coordinating with the Management Representative and Person Responsible for Regulatory Compliance as necessary.
- Effectively influence and mobilize key stakeholders toward desired results and future-state that enables the company’s future growth.
- Responsible for maintaining a deep understanding of new and existing regulations that may impact their organization’s products and processes. Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.
- Train process owners, employees, and stakeholders, as necessary, to the applicable regulations, procedures, and policies
- Reviews, prepares, and maintains regulatory files (administrative documents and technical documentation in format required by local laws, regulations, and standards) for new and/or changed products and submits to applicable authorities.
- Develop talent within team to increase performance.
- Support the development of annual budgets. Make necessary changes with appropriate management involvement.
NATIONAL, INTERNATIONAL AND STATE LICENSING
- Identify state, national, and international medical device regulations and ensure the appropriate clearances and agreements are in place prior to company distribution.
- Coordinate and complete global submissions for market access.
- Track US and international licensing to ensure renewal applications and updates are completed in the timeframes defined. Guide and support other team members with the execution of tasks related to US and international licensing.
- Manage relationships within the relevant regulatory agencies to improve quality of submissions and understand the impact of any pending or proposed regulatory changes.
- Compile licensing application to ensure that the specific international, national, and state requirements outlined.
- Support and lead projects, as assigned, related to the implementation of new regulatory requirements as issued by the US FDA, Health Canada, Australia, Japan, Brazil, the EU, or any other applicable region.
- Provide approved regulatory documentation to internal and external Customers as requested.
- Manage the creation and maintenance of Technical Files.
VIGILANCE / POST MARKET SURVEILLANCE
- Manage the adverse event reporting program (identify, investigate, and report) for the Perma Pure Group in compliance with the applicable regulations as outlined by (but not limited to) international regional competent authorities, notified bodies, and Customer agreements. Coordinate with the Person Responsible for Regulatory Compliance and the Management Representative, as necessary.
- Manages complaint initiation and review of each Maxtec complaint to determine if it is a reportable event in accordance with the applicable regulations including but not limited to US FDA 21 CFR Part 803, EN ISO MDSAP countries.
- Lead and contribute to the execution of Post Market Surveillance plans and execution such as Post Market Surveillance Reports, Periodic Safety Update Reports, and Clinical Evaluations.
JOB ESSENTIALS:
- Working knowledge of 21CFR Part 820, 803, 801, EN ISO 13485:2016, MDSAP, EU Medical Device Regulation
- Experience in searching medical literature databases for clinical and technical information.
- Strong ability to collect and analyze data to identify patterns and potential liabilities is still often a part of the job description for many.
- Ability to read, analyze, and interpret clinical literature, regulations, guidance documents, clinical and medical terminology, technical product information and complex documents.
- Maintain a deep understanding of the products or services offered by our company and the broader medical device industry in which we operate and the agencies that regulate it.
- Utilize people skills to influence members across functions and companies.
- Strong written and verbal communication skills and proven ability to present to internal and external stakeholders
- Strong and proven problem-solving skills
- Ability to travel to work with customers and suppliers
- Computer proficiency in Microsoft Office products (Excel, Outlook, PowerPoint, Word, Teams)