Jobseeker: Login or Create Profile

Your Messaging Here

Featured Employers

Featured Jobs

View More Jobs

Sign In
 [New User? Register]
Mobile Version

Regulatory Affairs Manager


Mansfield, MA
Job Code:
  • Healthcare
  • Management
  • Financial Services
  • Marketing
  • Engineering
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

Company Medtronic
Job Title Regulatory Affairs Manager
JobId 33255
Location: Mansfield, MA, 02048, USA

Regulatory Affairs Manager


Mansfield, Massachusetts, United States

Requisition #:


Post Date:

Aug 30, 2017


The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.

**RENAL CARE SOLUTIONS** strives to improve outcomes, access, and quality of life for patients affected by renal disease.


TheRegulatory Affairs Manageris responsible for worldwide product approval submission activities for assigned projects. This position is responsible to implement policies, procedures, practices and strategies for Regulatory Affairs. Collaborate with RD, Clinical, and Quality and other required functions to execute regulatory strategy from product inception, launch and throughout the product lifecycle. Manages activities the department,with responsibility for results in terms of costs, methods and employees. This working manager position accomplish results through hands on and delegation of responsibility to individual contributors. Provides leadership, coaching and career development for other Regulatory Affairs Specialists


+ Develop global regulatory strategies for medical device, pharmaceutical, and combination product to meet business objectives.

+ Participate on Product Development teams, providing regulatory strategy, timelines, and direction. Review and approve design verification, design validation and stability protocols and reports.

+ Organize and prepare high quality pre and post market submissions for global markets and work with Regional Business Units to obtain and maintain global product regulatory documentation, approvals and product renewals.

+ Negotiate with regulatory authorities to resolve questions/issues that arise during submission review.

+ Drive product change assessments and define regulatory impact of product changes in global markets. Provide documentation to geographies that require a submission or amendment.

+ Review and approve labeling, training, promotional, and advertising material.

+ Maintain Regulatory Affairs product files and ensure compliance with regulatory requirements. Ensure compliance with Medtronic, U.S. FDA, and international requirements.

+ Assist in reviewing, assessing impact and informing management of new and changing global regulatory requirements.

+ Interprets and executes policies and procedures that typically affect subordinate organizational units. Recommends modifications to operating policies. Create and maintain regulatory affairs department procedures that comply with applicable global regulatory laws/standards and Company policies and procedures.

+ Participate on audit and field action teams.

+ Sponsor and actively monitor a performance management culture where employees have clear performance expectations. Provide targeted coaching and feedback. Clearly identify and communicate the differentiation of talent and assure development actions and rewards align accordingly. Conduct timely and candid performance evaluations. Support meaningful development activities.



+ Bachelor’s Degree in science, math or engineering discipline. Advanced degree desired.


+ 9+ years medical device industry experience with 5 years regulatory experience. (Or advanced degree with 7 years industry experience.)

+ 3+ years of experience providing work direction and leadership to people and teams


+ Good oral and written communication skills

+ Detail oriented and good program management skills

+ Proactive problem solving skills

+ Able to work in cross-functional teams

+ Ability to prioritize work and flexible in work assignments

+ Ability to work in an international environment, with delocalized teams and diverse cultures.

+ Knowledge of international medical device / drug regulations

+ Ability to work in a multicultural team


+ Experience with pre and post market activities including, but not limited to, Investigational Device Exemptions, premarket notification applications [510(k)], premarket approvals [PMA], technical files, procedures packs, and design dossiers. Additionally, experience with evaluating change to existing commercially available products.

+ Class I, II, III medical device experience and in-depth knowledge of FDA medical device regulations. Combination product, tissues of animal origin, and/or pharmaceutical experience desired.

+ Thorough knowledge of FDA, EEA and other international regulations pertaining to the design, manufacture and commercialization of medical devices as well as regulatory Compliance competency (e.g. Inspections, Audits, Field Actions).

+ Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485:2003

+ Vascular access product experience desired.


+ Fast-paced office environment

+ Significant use of computer keyboard, monitor, and mouse.

+ 10-20% travel, including international may be required.


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.


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 at :// at


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.

As a global leader in medical technology, we serve patients and partner with medical professionals in 120 countries. Below are our main regional offices; key manufacturing, service, and research and development facilities; and Bakken Education Centers for physician training.

Powered ByLogo
© 2010 Adicio Inc.