JOB OBJECTIVE: Assist with regulatory support to different areas of the company to ensure that Promega products comply with relevant domestic and international medical device and electrical equipment regulations. Assist with the development and maintainance of required documentation to support regulated products.
1. Understand, investigate and evaluate regulatory requirements.
2. Provide regulatory support for Promega products throughout the product lifecycle.
3. Prepare, evaluate and maintain the ERP system classifications for Promega products.
4. Maintain documentation needed to support regulated product throughout the product’s lifecycle.
5. Review and approval of product labeling.
6. Review and approval of product literature for compliance to applicable regulations.
7. Review and approve advertising and promotional literature to ensure compliance to intended use.
8. Assist with risk assessments for regulated products.
9. Evaluate risks based on regulatory factors; provide options and recommendations to mitigate risk.
10. Supporting Regulatory Affairs domestically as well as European registrations and submissions, technical file maintenance, recall coordination and medical device reporting.
11. Support creation and maintenance of technical files and Declarations of Conformity in support of EU product registrations/CE mark.
12. Stay up-to-date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers.
13. Support company registrations and device listings in the US, Canada, EU, China, and others as needed.
14. Supports internal/external audits and regulatory inspections.
15. Understand and comply with ethical, legal and regulatory requirements applicable to our business.
1. Bachelor's Degree (B.S.) from a four-year college or university in Engineering, Bio-Medical Engineering, Sciences or related field.
2. Minimum of 1 – 2 years of Regulatory Affairs or Quality Assurance work experience.
3. Current knowledge of FDA and International quality system regulations required.
4. Experience following Device Design Controls and Risk Management Processes.
5. Experience with IVDs, Electronic Medical Equipment is a plus.
6. Must be able to work with minimal direction. Strong attention to detail and sound ability to interpret, translate and address regulatory needs.
7. Experience in various software and database applications to enhance individual productivity.
8. Strong oral and written communication skills. Demonstrated ability to read, understand and assist others in developing means to comply with regulations while meeting business needs.
1. Bachelor’s Degree preferably in a scientific, engineering, regulatory, internal audit, pre-medical, legal, or general business core concentration.
2. 2 – 4 years of combined Regulatory and Quality experience.
3. Experience with Canada, EU and other international countries submissions.
4. MDR and Vigilance reporting, eMDR and UDI experience.
5. Experience working within a quality system such as ISO 9001, ISO 13485, FDA cGMP.
6. Experience with the FDA Guidance document for RUO/IUO products
1. Ability to work with computer equipment.
2. Ability to move boxes weighing up to 30 lbs.
3. Ability to use PPE as necessary to perform assigned tasks.
Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.