Regulatory Operations Specialist

Medtronic•Eatontown, NJ

2d•Remote

About The Position

The Regulatory Operations Specialist is part of the Regulatory Affairs Data & Product Release Group within the Medtronic Clinical & Regulatory Solutions (MCRS) organization. This role supports global regulatory systems and processes, ensuring high standards of regulatory compliance, data integrity, and operational efficiency. The position plays a critical role in the execution and continuous improvement of regulatory operations, with primary responsibility for supporting systems and processes related to RAC/RAN, GTS, RIM, and Unique Device Identification (UDI). This role partners closely with cross-functional stakeholders to enable compliant and scalable regulatory change and data management and product release activities. This role primarily interfaces with regulatory affairs teams, operating unit (OU) regulatory teams, regulatory operations teams, manager and director. A role in MCRS offers unique experience opportunities, such as: being part of a global team, collaborating with business partners throughout the company, visibility to global structures and impacts, and insight to various processes and functions across Medtronic. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts.

Requirements

Bachelors degree plus 2+ years of related Medtronic experience
Strong Communication Skills: Strong written and oral communication skills to effectively interact with regulatory agencies and cross-functional teams.
Organizational Skills: Strong time management skills, with the ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines.
Independence and Initiative: Ability to work independently under general direction.
Computer Skills: Proficiency in MS Office, MS Project, Power BI, Adobe Acrobat, and Agile.
For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

2+ years of industry experience, with at least 2+ years in regulatory, clinical, or quality roles.
Experience working in a regulated biotechnology or medical device environment.
Intermediate knowledge of word processing, spreadsheet, database and graphics presentation applications (Microsoft Office, Adobe Acrobat, Documentum, SharePoint, PowerBI and Sitebuilder).
Organizational skills, highly detail oriented, and effective project management skills.
Flexible with changing priorities, self-motivated, strong work ethic, attention to detail, works well under pressure in a dynamic environment.
Tactful, exercises independent judgment and discretion, professional presentation, advanced communications skills (written and oral), team player, basic business acumen.

Responsibilities

Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training, developing and implementing plans, and providing input to systems designs.
Leading Regulatory Operations Committee
Leading data mining and data cleansing activities
Basic understanding of regulatory requirements and approach for researching detailed requirements

Benefits

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)