Associate Regulatory Prooduct and Operations Specialist
- 170003ZY Requisition #
- Mar 22, 2017 Post Date
SUMMARY OF POSITION:
The Regulatory Affairs Associate is responsible for assistance with management of the Regulatory Affairs department activities, supporting US FDA and EU submissions and the support in managing international regulatory registrations with the Regional Business Units (RBU), which includes global regulatory strategies and impact assessments, initial registrations, re-registrations and notifications/registrations of changes that may impact the regulatory approvals.
- Collaborate and support RBUs to determine local regulatory pathways, requirements and timelines.
- Collaborate with, and support RBUs by providing the documentation necessary to prepare in-country regulatory submissions. Including, but not limited to obtaining Certificates to Foreign Government, Letter of Authorization, technical reports, and the notarization of documents.
- Collaborate with and support RBUs in coordinating international regulatory activities on behalf of the Surgical Innovations business.
- Ensure the timely and accurate filing of regulatory documentation.
- Develop and maintain product technical files.
- Maintain product licenses by providing annual notifications as required by specific regions.
- Assist in the development, documentation, and implementation of regulatory strategies for new technologies and product modifications to include applicable international requirements.
- Provide regulatory affairs support to new product development teams.
- Provide regulatory affairs support to design and change control teams to assess regulatory impact of design changes.
- Actively maintain and report registration status with applicable registration trackers and applications.
- Perform other regulatory affairs duties when requested.
- Interface with quality, operations, clinical, regulatory, sales, marketing, and administrative staff as necessary to accomplish the above responsibilities.
- May have to travel internationally.
- Ensures rapid and timely responses to requests from regulatory agencies and third party registrars.
- Completion and distribution of vendor surveys along with supporting documentation to allow products to be sold and used in various custom kit configurations.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Performs other duties and responsibilities, as required.
- Bachelor’s degree in a scientific or engineering field
- Bachelor’s degree in any field and 2 years of experience in a Medical Device or similar regulated industry
- 0 – 2 years related experience in a technical job function/role, depending on degree type.
- Experience in a regulated industry, preferably medical devices, with an emphasis in regulatory or quality assurance
- Excellent verbal and written communication skills
- Experience using ERP software (BPCS/SAP preferred), electronic filing systems, and/or databases
- Ability to interface effectively with individuals from a wide variety of disciplines to research and obtain appropriate documentation for the submission of regulatory information.
- Ability to prepare and submit regulatory documentation packages.
- High Level of proficiency using MS Excel and MS Word.
- Working knowledge of MS Access, MS Project, and Adobe Acrobat Pro.
- High learning aptitude and adaptability with software systems
- Demonstrated technical writing skills.
- Multi-tasks and prioritizes effectively in fast-paced environment
- Highly organized, detail oriented, and efficient.
- Highly self-motivated
- Team player who seeks to help and learn from colleagues seeing the department success as their own
- A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
- Demonstrated leadership qualities
- Ability to manage small scale projects to completion within and outside of the direct department.
- Strong interpersonal and negotiation/influencing skills while maintaining a high level of professionalism
- Proactively seeks to develop and become well-versed within in the regulatory landscape.
- Reports to a Manager of Regulatory Affairs
- Works directly with the Director and/or Manager of Regulatory affairs on FDA and European, and international regulatory matters when required.
- Works with supervisors and managers outside of RA during the course of registration preparation.
- Works with state personnel and foreign consulates/embassies personnel as appropriate.
- Works with project team members and other company personnel as required.
- Communicates with FDA, European Notified Body, and international regulatory counterparts regarding status of regulatory submissions and other regulatory matters
- Telephone, personal computer, copy machine, scanner and facsimile machine
- Usual office environment with frequent* sitting, walking, and standing, and occasional* climbing, stooping, kneeling, crouching, and balancing.
- Position requires less than 10% travel.
- Ability to move from department to department and building to building to attend meetings, conduct audits, and perform product investigations.
- Frequent* use of eye, hand, and finger coordination enabling the use of office machinery.
*Occasional: Activity exists less than 1/3 of the time.
*Frequent: Activity exists between 1/3 and 2/3 of the time.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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 physical demands described within the Responsibilities 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
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.