B. Pharma/M. Pharma Opportunity as a Regulatory Affairs Specialist at Medtronic – Apply Now for Impactful Healthcare Leadership

WhatsApp D. Pharma Group Join Now
Telegram D. Pharma Group Join Now
Telegram Group Latest Pharma Jobs Join Now
Telegram B. Pharma Group Join Now
Telegram Medicine Update Group Join Now
WhatsApp B. Pharma/ GPAT Channel Join Now

Welcome to a career-defining opportunity in the dynamic realm of Regulatory Affairs at Medtronic! If you hold a degree in Pharmacy (B. Pharma/M. Pharma) and possess a passion for ensuring the highest standards of compliance and quality within the healthcare industry, this is your chance to shine. As a Regulatory Affairs Specialist at Medtronic, you’ll be at the forefront of shaping the regulatory landscape for innovative medical technologies that transform patient lives.

Regulatory Affairs Specialist

As a Regulatory Affairs Specialist at Medtronic our commitment to excellence, coupled with your expertise in pharmaceutical regulations, creates the perfect synergy for a rewarding professional journey. In this role, you will play a pivotal part in navigating the complex regulatory environment, ensuring that our cutting-edge medical devices meet stringent standards and gain timely approvals.

Position: Regulatory Affairs Specialist

Careers that Change Lives
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 .

A Day in the Life
1. 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 India.
2. Coordination with global regulatory teams, local BU & other functions, for regulatory strategies and all documentation support required for regulatory submissions in India.
3. Submit and track registration/re-registration applications with the authorities.
4. Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses.
5. 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.).
6. Understanding & interpretation of law & the local regulatory requirement and implementing same in submission with compliance.
7. 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.
8. 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.
9. Supporting the Marketing Teams on Tender related issues
10. Development, implementation and maintenance of regulatory systems pertaining to regulatory document management (SOP’s, archival, trackers and systems) within the department and organization.
11. 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.
12. 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 India.

Qualifications – External
Must Have – Minimum Requirements
1. B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs
2. 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
3. Conversant with various regulatory requirements for India with respect to medical device registration, import, clinical trials, etc.
4. 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

Nice to Have
1. Excellent communication and interpersonal skills – Good verbal communicator and presenter
2. Customer focused: Understands and delivers customer service
3. Ability to quickly establish credibility with all levels of Regulatory Agencies, Government, etc.
4. Good verbal and written communication skills in English – with colleagues, management and external authorities
5. Self-motivated and positive “Can do” attitude. Can work autonomously but is also a team player
6. Outgoing and friendly: Enthusiastic, energetic, diplomatic, willingness to learn
7. Be able to plan, manage, organize and report in an efficient way
8. Be independent, persuasive, innovative and able to summarize
9. Good time management: Well organized, able to set and reset priorities

External Focus
1. Interacts regularly with customers and seeks inputs.
2. Well informed regarding market and industry / competitors operating in territory.
3. Initiates or champions changes from the outside in.
4. Explores new opportunities and asks informed questions.
5. Experience of dealing with various functions internally and externally

1. Consistently delivers results on time and exceeds expectations.
2. Ensures the processes are capable of achieving the desired direction
3. Clarifies roles and aligns resources allowing for faster execution.
4. Orchestrates resources for optimal use. Continually monitors progress and seeks continuous improvement.

Inspires Others
1. Has the ability to connect ,motivate, engage the sales force
2. Builds networks to obtain cooperation without relying on authority.
3. Makes active attempts to influence events to achieve goals
4. Establishing procedures to monitor the results of delegations, assignments, or projects;
5. Seeks and values different perspectives and ideas to foster an inclusive work environment

Clear Thinking
1. Understands strategic contexts, identifies opportunities
2. Is able to anticipate risks, evaluate options and defines priorities for the team
3. Establishing a course for self and for others to accomplish a specific goal; planning proper assignments of personnel and appropriate allocation of resources.
4. Committing to an action after developing alternative courses of action that are based on logical assumptions and factual information and that take into consideration the resources, constraints and organizational values.

Mission values
1. Derived from the Mission
2. Ensures compliance and quality in everything we do at Medtronic

Compliance & Integrity
1. Models the highest standards of honesty, ethics, and integrity.
2. Consistently promotes and adheres to letter and spirit of Medtronic Code of Conduct, all applicable laws, and company policies.
3. Promotes and ensures an environment where ethical behavior is expected and unethical behavior is not tolerated.
4. Expeditiously takes appropriate action when problems occur.

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 ssential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, he employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers.


<<<<<<<<<<<<<MORE JOBS>>>>>>>>>>>>>>>>

Walk-in Interview as Project Technical Support-III at ICMR – National Institute of Nutrition in Hyderabad More Info..
Recruitment of Pharmacist/Pharmacist Grade II/Pharma Chemist/Chemical Examiner/Dispensing Attendant (100 Posts) at AIIMS More Info..
Applications are invited for the Post of Scientific Officer (09 Post) Under GPSC More Info..
Opportunity as a Consultant Scientific & Project Research Scientist under ITRC-ICMR More Info..
Recruitment of Assistant Professor (Biotechnology) at NIPER Guwahati – Apply Now More Info..
Opportunity for B. Pharma/ M. Pharma Freshers as Regulatory Affairs Intern Trainee at Genedrift – WFH Job More Info..
Applications are invited for Senior Research Fellow at Punjab University, Chandigarh More Info..
AstraZeneca is hiring Regulatory Affairs Manager – Apply Now More Info..
Fortera is hiring Safety Science Analyst – Apply Now More Info..
Recruitment of Project Assistant at Regional Centre of Biotechnology – 27th November 2023 More Info..
Vacancy for Project Technical Support-III at Department of Pharmaceutical Engineering & Technology, IIT-BHU, Varanasi
More Info..
Recruitment of Pharmacist (05 Post) under Directorate General of Health Services More Info..
Recruitment of Junior Research Fellow at National Institute of Technology Rourkela – Apply Now More Info..
Walk-in Interview for B. Pharma/ M. Pharma in Quality Control Department at Intas Pharmaceuticals – 17th November 2023 More Info..
Recruitment of Drug Sampler at Central Drugs Standard Control Organization (CDSCO) – Apply Now More Info..
Opportunity for B. Pharma Candidates as Clinical Trial Coordinator at IPGMER Kolkata – Apply Now More Info..
Recruitment of Jr. Pharmacist (02 Post) at Central Medical Services Society under BECIL – Apply Now More Info..
Vacancy of Associate Consultant at BIRAC (Biotechnology Industry Research Assistance Council)- Apply Now More Info..
Recruitment of Pharmacist under Directorate of Medical & Hearth services, Dadra & Nagar Haveli More Info..
Recruitment of Pharmacist (02 Post) at Urban Primary Health Center – Apply Now More Info..
Vacancy of Pharmacist (09 Post) under Zilla Swasthya Samiti – Apply Now More Info..
Jubilant Generics Limited is Hiring B. Pharma/M. Pharma/B. Sc. Lifescience Candidates as Executive/Sr. Executive – Pharmacovigilance
More Info..
Walk-in Interview for B.Sc./ B. Pharm/ B. Tech/ M. Sc./ M. Pharm for Production Department at MSN Laboratories Pvt. Ltd. More Info..
Recruitment of Technical Assistant/ Documentation Assistant at Regional Centre for Biotechnology – B. Pharma/ BE/ B. Tech/ B. Sc can apply
More Info..
Career Opportunity as Project Scientific Assistants at Tata Institute of Fundamental Research – B. Pharma/ B. Sc/ BV Sc. can apply More Info..
Recruitment of Assistant Professor/ Associate Professor (07 Posts) at AKTU, Lucknow -Apply Now More Info..
Opportunity for B. Pharma/ M. Pharma as Regulatory Affairs Associate at Teva Pharmaceuticals More Info..
Parexel is hiring Pharma Candidates as Principal Medical Writer – Apply Now More Info..
Macleods Pharmaceuticals is hiring M. Pharma/ M. Sc. candidates as Quality control officer for QC department – Apply Now More Info..
Opportunity for Pharma Candidates as Junior Research Fellow at MNNIT, Allahabad – Apply Now More Info..
Recruitment of Junior Research Fellow at Panjab University, Chandigarh – Apply Now More Info..
Applications are invited for Pharmacist Post at Health Medical & Family Welfare Department More Info..
Vacancy for Pharma Candidates for R & D Department at Patanjali Research Foundation – Apply Now More Info..
Vacancy for Laboratory Technician (Pharmacy) under Kerala PSC – Apply Now More Info..
Recruitment of Pharmacist (02 Post) under Kerala PSC – Apply Now More Info..


<<<<<<<<<<<<<JOIN US>>>>>>>>>>>>>>>>

Subscribe our PHARMACY INDIA Youtube Channel for more Pharma Updates Click Here
Follow us on Instagram Click Here
Download PHARMACY INDIA MOBILE APP from Google Play Store  Click Here
Follow us on LinkedIn Click Here


Please enter your comment!
Please enter your name here