Regulatory Affairs Specialist

At Medtronic you can begin a life-long career of exploration and innovation,
while helping champion healthcare access and equity for all. You’ll lead with
purpose, breaking down barriers to innovation in a more connected, compassionate
world. A Day in the Life Responsible for implementation of regulatory compliance
systems and support Regulatory Affairs activities of India Medtronic. He/she
participates in all activities relating to preparation, submission and follow up
to obtain approvals/renewals for products and its variations & line extension
indications and labeling approvals of medical devices of various business units
of Medtronic. He/ she will be responsible for providing technical support by
interpreting federal and local regulations as they apply to products, processes,
practices and procedures. Responsibilities may include the following and other
duties may be assigned. Manage, plan and execute the preparation, review and
submission of dossiers for product registrations, import licenses and other
approvals from regulatory agencies (registrations and renewals) thereby
supporting the business units and supply chain management in compliance with
regulatory requirements in the Indian Sub-Continent (India, Sri Lanka,
Bangladesh, Nepal) Coordination with global regulatory teams, local BU & other
functions, for regulatory strategies and all documentation support required for
regulatory submissions in Indian Sub-Continent. Submit and track
registration/re-registration applications with the authorities. Liaise with
product divisions and obtain relevant details for filing changes to the approved
products/licenses. Assess the Change controls from the product divisions through
post approval change management and continuously ensure regulatory compliance
(reporting of adverse events/field actions, etc.). Understanding &
interpretation of law & the local regulatory requirement and implementing same
in submission with compliance. Close monitoring of any changes in local & global
regulations and communicating same within the department and respecting &
following all SOP / system implemented within the department and organization.
Ensure business continuity through regulatory filings, obtaining regulatory
approvals and continuously ensuring regulatory compliance. Also ensure
continuous implementation of the Quality Management System in India. Supporting
the Marketing Teams on Tender related issues Development, implementation and
maintenance of regulatory systems pertaining to regulatory document management
(SOP's, archival, trackers and systems) within the department and organization.
Interface and coordinate with regulatory agencies/competent authorities (CDSCO,
CDDA, DGDA, State FDA, DoT, AERB, etc.) with respect to submissions, obtaining
registrations/licenses, amendments, regulatory compliance, packaging, quality
control testing or release, etc. Work with clinical team on submission and
approval of clinical trials applications (clinical trial approvals, import
licenses/test licenses for clinical trial, amendments, etc.) from various
regulatory agencies in the Indian Sub-Continent SPECIALIST CAREER STREAM:
Typically an individual contributor with responsibility in a professional
discipline or specialty. Delivers and/or manages projects assigned and works
with other stakeholders to achieve desired results. May act as a mentor to
colleagues or may direct the work of other lower level professionals. The
majority of time is spent delivering and overseeing the projects – from design
to implementation - while and adhering to policies, using specialized knowledge
and skills normally acquired through advanced education. DIFFERENTIATING FACTORS
Autonomy: Established and productive individual contributor. Works independently
with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives
of projects and assignments. Contributes to the completion of project milestones
. May have some involvement in cross functional assignments. Innovation and
Complexity: Problems and issues faced are general, and may require understanding
of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve
problems or improve effectiveness of job area. Communication and Influence:
Communicates primarily and frequently with internal contacts . External
interactions are less complex or problem solving in nature. Contacts others to
share information, status, needs and issues in order to inform, gain input, and
support decision-making. Leadership and Talent Management: May provide guidance
and assistance to entry level professionals and / or employee in Support Career
Stream. Required Knowledge and Experience: Requires practical knowledge and
demonstrated competence within job area typically obtained through advanced
education combined with experience. B Pharm / M Pharm / Bachelor or Master
Degree in Bio-Medical Engineering / Science discipline with training in
Regulatory Affairs Must have at least 5-7 years’ experience in the
pharma/medical device/life science industry with at least 2-3 years' medical
device experience in regulatory affairs Conversant with various regulatory
requirements for India, Sri Lanka, Bangladesh & Nepal with respect to medical
device registration, import, clinical trials, etc. Knowledge in application of
CDSCO, FDA, CE and other regulatory requirements especially in the area of
Quality Systems and Design Control as applied to projects from design inception
to manufacturing release Attributes: Excellent communication and interpersonal
skills - Good verbal communicator and presenter Customer focused: Understands
and delivers customer service Ability to quickly establish credibility with all
levels of Regulatory Agencies, Government, etc. Good verbal and written
communication skills in English - with colleagues, management and external
authorities Self-motivated and positive "Can do" attitude. Can work autonomously
but is also a team player Outgoing and friendly: Enthusiastic, energetic,
diplomatic, willingness to learn Be able to plan, manage, organize and report in
an efficient way Be independent, persuasive, innovative and able to summarize
Good time management: Well organized, able to set and reset priorities 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.  Benefits & Compensation Medtronic offers a competitive
Salary and flexible Benefits Package A commitment to our employees lives at the
core of our values. We recognize their contributions. They share in the success
they help to create. We offer a wide range of benefits, resources, and
competitive compensation plans designed to support you at every career and life
stage. This position is eligible for a short-term incentive called the Medtronic
Incentive Plan (MIP). About Medtronic We lead global healthcare technology and
boldly attack the most challenging health problems facing humanity by searching
out and finding solutions. Our Mission — to alleviate pain, restore health, and
extend life — unites a global team of 95,000+ passionate people. We are
engineers at heart— putting ambitious ideas to work to generate real solutions
for real people. From the R&D lab, to the factory floor, to the conference room,
every one of us experiments, creates, builds, improves and solves. We have the
talent, diverse perspectives, and guts to engineer the extraordinary. Learn more
about our business, mission, and our commitment to diversity here We lead global
healthcare technology and boldly attack the most challenging health problems
facing humanity by searching out and finding solutions. Our Mission — to
alleviate pain, restore health, and extend life — unites a global team of
95,000+ passionate people. We are engineers at heart— putting ambitious ideas to
work to generate real solutions for real people. From the R&D lab, to the
factory floor, to the conference room, every one of us experiments, creates,
builds, improves and solves. We have the talent, diverse perspectives, and guts
to engineer the extraordinary. We change lives. Each team member, each day,
helps to improve and redefine how the world treats the most pressing health
conditions, from heart disease to diabetes. Our industry leadership comes from
the passion and ingenuity of our people. That’s who we are. Working alongside
one another, we use science, medicine, and a profound understanding of the human
body to build extraordinary technologies that can transform lives. We build
extraordinary solutions as one team. With one Medtronic Mindset defining how we
work. Speed and decisiveness run through our DNA. Diverse perspectives inspire
our bold answers to any challenge that comes our way. And we deliver results the
right way, breakthrough after patient breakthrough. This life-changing career is
yours to engineer. By bringing your ambitious ideas, unique perspective and
contributions, you will… Build a better future, amplifying your impact on the
causes that matter to you and the world Grow a career reflective of your passion
and abilities Connect to a dynamic and inclusive culture that welcomes the
challenge of life-long learning These commitments set our team apart from the
rest: Experiences that put people first. Respect for people is the hallmark of
our humanity. It fuels our team to positively impact even a single life. And it
means we put our people first at Medtronic as well, creating a culture of
belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies. No matter your role, you contribute to
technologies that transform lives. What we build empowers patients to live life
on their terms. Better outcomes for our world. Here, it’s about more than the
bottom line. Our Mission to improve human welfare drives us. We advance
healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care. Fresh viewpoints. Cutting-edge AI, data, and automation.
You're shaping the future of healthcare technology and defining the next
generation of breakthroughs in care 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. For sales reps and
other patient facing field employees, going into a healthcare setting is
considered an essential function of the job and we expect our employees to
comply with all credentialing requirements at the hospitals or clinics they
support. 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. For updates
on job applications, please go to the candidate login page and sign in to check
your application status. If you need assistance completing your application
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from our systems please email RS.HRCompliance@medtronic.com