Regulatory Compliance Manager, Req: 2021-01
Altimate Medical Inc. (AMHI) is looking for a Regulatory Compliance Manager. This key position will maintain our Regulatory Compliance system. The Regulatory System is integrated into the Quality Management System (QMS) to ensure the activities of AMHI conform to and are compliant with the Food & Drug Administration Regulations, Canadian Medical Device Regulations, European Medical Device Regulation, and other applicable regulations.
Location: Altimate Medical is located in Morton, MN. Minnesota candidates in and around the area are encouraged to apply as travel to the Morton facility will be required from time to time. Applicants working and living near our MPI office in Kansas City, KS are also encouraged to apply and work from that location.
Specific Job Duties/Responsibilities:
- Provide regulatory support for multiple Class I and Class II medical devices in US & global markets for the family of AMHI Companies.
- Ensure compliance with national and international regulatory requirements for existing and new medical devices.
- Classify products per the applicable country’s regulations where the products will be marketed.
- Prepare, review, and submit any applicable regulatory submissions.
- Compile & review technical documentation per applicable requirements.
- Review clinical literature and complete clinical evaluation reports on the medical devices per applicable requirements.
- Prepare and maintain product listings and establishment registrations for US and Canada.
- Prepare and provide the applicable documentation to obtain and/or maintain pre-determined international registrations per applicable requirements.
- Request Certificates to Foreign Government from the FDA as products are released to the market.
- Support post-market surveillance activities.
- Prepare & submit applicable regulatory reports as applicable.
- Evaluate proposed product changes for regulatory impact.
- Interact with regulatory authorities and/or representatives/sponsors during any registration and/or submission/review process to ensure product approval as applicable.
- Evaluate and interpret requests/direction provided by international representatives/sponsors to ensure proper alignment with requirements.
- Review and approve product labeling and promotional materials to assure compliance with applicable regulatory requirements.
- Manage GUDID coordination and labeler accounts for UDI compliance.
- Research and maintain current knowledge of changes to applicable laws, regulations, and industry standards. Assist in the communication of this information to the appropriate individuals within the company.
- Identify regulatory obstacles and emerging issues and work with other team members to develop solutions.
- Assist Product Development in completion of checklists for applicable design & testing requirements.
- Collaborate with Quality Manager/QMS Rep to assist with SOP development and updates (as applicable).
- Participate in internal and external audits.
- QST Member (Quality Steering Team)
- Shares information regarding regulatory issues/developments.
- Attend Management Review meetings
- Other duties as assigned.
Education and/or Experience:
- Bachelor’s Degree in scientific discipline or related field
- Minimum 3+ years’ professional experience in regulatory affairs or in quality management systems related to medical devices.
- Experience with FDA requirements, Canada Medical Device Regulations, European Union Medical Device Directive, and new EU MDR requirements required.
- Experience with ISO 14971, ISO 13485, IEC 60601, and other quality standards preferred.
- Experience working with cross-functional teams.
- Experience working with technical documentation.
- Ability to comprehend principles of engineering, human anatomy, and medical device use.
- Ability to effectively manage multiple projects and priorities.
- Strong organizational skills and time management skills
- Excellent oral and written skills
- Excellent analytical thinking skills
- Proficient computer skills
- Ability to travel up to 20% (domestic)
- Stop production if any process adversely affects product quality.
- Have the authority to identify and evaluate quality issues in their position and to initiate, recommend and provide effective corrective actions to any quality problem.
- Stop production if any process/condition poses a safety hazard.