Regulatory Affairs Specialist.

4 weeks ago

hyderabad, India Medtronic Full time

Careers that Change Lives

Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations.Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met.Responsible for supporting the needs of the MEIC with regulatory support for research and development activities and ensuring Indian and other applicable regulations and policies are met.

A Day in the Life

Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments. 

Must Have

Job Responsibilities

·Prepare, review, file, and support premarket documents for global registrations for assigned projects.

·Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.

·Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization.

·Review pre-clinical, and clinical protocols and associated reports to be used in submissions for assigned projects.

·Develop Regulatory Strategies for new or modified products for assigned projects.

·Monitor and provide information pertaining to impact of changes in the regulatory environment.

·Communicate with regulatory agencies and/or notify bodies on administrative and routine matters.

·Document, consolidate, and maintain oral and written communication with health authorities

·Prepare internal documents for modifications to devices, when appropriate.

·Participate in health agency inspections & notified body audits as necessary.

·Author and/or review regulatory procedures and update as necessary.

·Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments.

·Assist in development/maintenance of regulatory files, records, and reporting systems of systematic retrieval of information.

·Review promotional material, advertising, and labeling to ensure regulatory compliance on assigned projects.

·Ensure compliance to regulations specific to clearance and approvals of MEIC developed product’s raw material and/or prototype.

Minimum Qualifications

·Bachelor degree in Medical, Mechanical, Electric Life Science or other healthcare related majors

·4-7 years experiences for RA role in medical device and or pharmaceutical industry

·Good understanding for regulations and policies issued by India, US FDA and EU, and ability to interpret international regulatory requirements.

·Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.

·Strong attention to details and ability to handle multiple tasks, good at planning and can work under pressure;
Good at English, including reading, writing, and speaking;

Good Learning attitude

Nice to Haves

·Excellent communication and interpersonal skills

·Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.

·Self-motivated and positive

·Ability to quickly establish credibility with all levels of customer base

  • Regulatory Affairs Specialist

    3 days ago

    Hyderabad, Telangana, India Medtronic Full time

    Careers that Change Lives Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations.Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met.Responsible for supporting the needs of the MEIC with regulatory support for research and...

  • Regulatory Affairs Specialist.

    4 weeks ago

    Hyderabad, India Medtronic Full time

    Careers that Change Lives Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations.Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met.Responsible for supporting the needs of the MEIC with regulatory support for research and...

  • Regulatory Affairs Specialist.

    2 weeks ago

    Hyderabad, India Medtronic Full time

    Careers that Change Lives Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations.Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met.Responsible for supporting the needs of the MEIC with regulatory support for research and...

  • Regulatory Affairs Specialist

    2 weeks ago

    Hyderabad, India Makro Full time

    Job Title: Regulatory AffairsSpecialistCompany:MakroCareLocation:Hyderabad Telangana(Onsite)CompanyDescription:MakroCare is aleading provider of regulatory and clinical development solutionsbased in Hyderabad Telangana. We specialize in offeringcomprehensive services in clinical research regulatory submissionsand scientific communication. Our team is...

  • Regulatory Affairs Specialist

    3 days ago

    Hyderabad, Telangana, India Makro Full time

    Job Title: Regulatory AffairsSpecialistCompany:MakroCareLocation:Hyderabad Telangana(Onsite)CompanyDescription:MakroCare is aleading provider of regulatory and clinical development solutionsbased in Hyderabad Telangana. We specialize in offeringcomprehensive services in clinical research regulatory submissionsand scientific communication. Our team is...

  • Regulatory Affairs Associate

    2 weeks ago

    Hyderabad, India Parexel Full time

    Hyderabad, India **Job ID** R0000012328 **Category** Regulatory / Consulting **ABOUT THIS ROLE**: **Regulatory Affairs Associate** Must have experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned...

  • Regulatory Affairs, Associate

    2 months ago

    Hyderabad, India Cellix Bio Full time

    Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. You will help make an impact on people’s lives and change futures every day. We are equally committed to bringing out your best and fostering a collaborative workplace built on trust and respect. We empower our people to take charge of their potential. We offer...

  • Regulatory Affairs Manager

    4 days ago

    hyderabad, India SteriMax Inc. Full time

    About Us SteriMax is the largest privately-owned injectable company in Canada. Our foundation rests upon the principles of providing high quality products, maintaining a reliable product supply, and supporting the needs of Canadian patients. For more details, please visit our website Detailed Responsibilities · Manages and provides leadership to an...

  • Regulatory Affairs Associate

    3 days ago

    Hyderabad, Telangana, India Parexel Full time

    Hyderabad, IndiaJob ID R Category Regulatory / ConsultingABOUT THIS ROLE:Regulatory Affairs AssociateMust have experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:Submission...

  • Regulatory Affairs Manager

    4 days ago

    Hyderabad, India SteriMax Inc. Full time

    About UsSteriMax is the largest privately-owned injectable company in Canada. Our foundation rests upon the principles of providing high quality products, maintaining a reliable product supply, and supporting the needs of Canadian patients. For more details, please visit our website www.sterimaxinc.comDetailed Responsibilities· Manages and provides...

  • Regulatory Affairs Associate, Post-Approval

    2 days ago

    Hyderabad, India SteriMax Inc. Full time

    POSITION DESCRIPTIONReporting to the Team Leader of Post-Approval Regulatory Affairs, the Regulatory Affairs Associate will prepare regulatory submissions for Health Canada and actively participate in the management of submissions under regulatory agency review in order to fulfill regulatory jurisdiction requirements. The Regulatory Affairs Associate is...

  • Regulatory Affairs Executive

    2 weeks ago

    Hyderabad, India SFC Full time

    Handling regulatory affairs in the pharma field. **Salary**: ₹200,000.00 - ₹600,000.00 per year **Benefits**: - Paid sick time - Paid time off Schedule: - Day shift Supplemental pay types: - Yearly bonus Ability to commute/relocate: - Hyderabad, Telangana: Reliably commute or planning to relocate before starting work...

  • Regulatory Affairs Executive

    2 weeks ago

    Hyderabad, India Novick bio sciences pvt ltd Full time

    **We are hiring an Executive in Regulatory Affairs** **Qualification **:B. Pharmacy/M. Pharmacy (Pharmaceuticals) **Experience**: 3- 4 yrs. **Location **:Balanagar (Hyderabad) **Date**: 28/08/2023 TO 05/09/2023 (Mon to Fri) **Time ** : 10 AM TO 4 PM **Skills Required**: 2) Update the registration dossiers, evaluate queries received from respective...

  • Regulatory Affairs Associate, Post-Approval

    3 days ago

    Hyderabad, Telangana, India SteriMax Inc. Full time

    POSITION DESCRIPTION Reporting to the Team Leader of Post-Approval Regulatory Affairs, the Regulatory Affairs Associate will prepare regulatory submissions for Health Canada and actively participate in the management of submissions under regulatory agency review in order to fulfill regulatory jurisdiction requirements. The Regulatory Affairs Associate is...

  • Regulatory Affairs Executive

    1 week ago

    Hyderabad, India Shiva's Farma Casa Pvt Ltd Full time

    Looking for a full time Regulatory Affairs executive with 1-3 years experience in APIs (Active pharmaceutical ingredients). No freshers. **Job Types**: Full-time, Regular / Permanent **Salary**: ₹200,000.00 - ₹980,116.12 per year **Benefits**: - Paid time off - Provident Fund Schedule: - Day shift Supplemental pay types: - Yearly bonus Ability...

  • Senior Regulatory Affairs Associate

    3 weeks ago

    Hyderabad, Telangana, India Parexel Full time

    Regulatory Affairs LabelingBachelor's Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)The...

  • Senior Regulatory Affairs Associate

    2 months ago

    Hyderabad, Telangana, India Parexel Full time

    Regulatory Affairs LabelingBachelor's Degree plus at least 5 to 8 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)The...

  • Regulatory Affairs Officer

    2 weeks ago

    Hyderabad, India Avasa Consultants Full time

    Hello Everyone, We are hiring for Senior Regulatory Affairs with 10+ Years of experience in API for Pharma company in Sadashivpet. **Job Types**: Full-time, Permanent **Salary**: ₹600,000.00 - ₹1,000,000.00 per year **Benefits**: - Provident Fund Schedule: - Morning shift Supplemental pay types: - Performance bonus - Yearly bonus Ability to...

  • Regulatory Affairs Associate, Post-Approval

    4 days ago

    hyderabad, India SteriMax Inc. Full time

    POSITION DESCRIPTION Reporting to the Team Leader of Post-Approval Regulatory Affairs, the Regulatory Affairs Associate will prepare regulatory submissions for Health Canada and actively participate in the management of submissions under regulatory agency review in order to fulfill regulatory jurisdiction requirements. The Regulatory Affairs Associate is...

  • Regulatory Affairs Associate, Post-Approval

    5 days ago

    Hyderabad, India SteriMax Inc. Full time

    POSITION DESCRIPTION Reporting to the Team Leader of Post-Approval Regulatory Affairs, the Regulatory Affairs Associate will prepare regulatory submissions for Health Canada and actively participate in the management of submissions under regulatory agency review in order to fulfill regulatory jurisdiction requirements. The Regulatory Affairs Associate is...