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Associate Regulatory Affairs Specialist
North Haven - Medtronic
ASSOCIATE REGULATORY AFFAIRS SPECIALIST
Careers that Change Lives
Global regulatory requirements are ever-changing. You will be a member of the Regulatory Affairs team that supports the Surgical Innovations (SI) business by assisting in the implementation of strategies that meet business objectives for new products.
Impact patient outcomes. Come for a job, stay for a career.
A Day in the Life
The Associate Regulatory Affairs Specialist provides general support within the regulatory affairs department, including assistance in areas of new product development, product changes, submissions (e.g., 510(k), CE technical file), international device registrations, and quality management systems.
The Associate Regulatory Affairs Specialist must demonstrate the following behaviors:
- Manage multiple projects and prioritize tasks on a daily basis
- Work effectively with colleagues in many functional areas
- Continuous improvement mindset, always looking for ways to improve the way we do our jobs
- Drive for personal development, including expanding breadth and depth of knowledge base, soft skills, and behaviors
- Careful evaluation of information and an eye for detail
- Assist in the implementation of regulatory strategies for new technologies and product modifications, considering both domestic and international regulations.
- Assist in the preparation of US FDA 510(k), technical documents, pre-submissions, investigations device exemptions (IDE), or de novo reclassification submissions
- Support international product registrations as needed
- Provide support to design teams and sustaining engineering; this includes regulatory input to bench and pre-clinical test requirements
- Evaluate information on competitive technologies as needed to identify appropriate predicate or comparable devices to be included in 510(k) submissions and clinical evaluation reports.
- Add and maintain regulatory information of internal shared databases
- Interface with engineering, clinical, regulatory, sales, marketing, and other functions as needed to fulfill project/task responsibilities
- Ensure completeness and accuracy in all regulatory documents
- Develop regulatory knowledge of domestic and international regulations, guidelines, and standards
- Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements
- Perform other duties as requested
Must Have: Minimum Qualifications
- Bachelor's degree in scientific or engineering discipline
- Proficient with MS Office software
- Demonstrated technical writing skills
Nice to Have
- Advanced degree
- Regulatory Affairs Certification (RAC) from RAPS
- Experience in the medical device-regulated industry
- Familiarity or working knowledge of international standards, such as IEC and ISO
- Prior experience with devices containing software
- Prior experience with risk management
- Familiarity with international regulatory requirements
- Familiarity with quality management systems requirements, including design controls
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees
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