Regulatory Affairs Executive

5 days ago

Dehra Dun, India Sunfox technologies Pvt Ltd Full time

**Company Overview**:
**Sunfox Technologies** is a forward-thinking and innovative medical device company committed to revolutionizing healthcare through advanced technologies. We are seeking a talented and motivated Medical Device Regulatory Affairs Executive to play a vital role in ensuring regulatory compliance for our cutting-edge medical devices. If you have a keen eye for detail, a solid understanding of medical device regulations, and a passion for contributing to the safe and successful market introduction of healthcare products, we invite you to join our team.

**Position Summary**:
As a Medical Device Regulatory Affairs Executive, you will be a crucial part of our regulatory affairs team, focusing on ensuring compliance with global regulations for our medical device portfolio. Your expertise in regulatory affairs will support the development, registration, and ongoing maintenance of our products, ultimately contributing to the improvement of patient care and outcomes.

**Key Responsibilities**:

- Collaborate with cross-functional teams, including R&D, Quality Assurance, Clinical Affairs, and Marketing, to integrate regulatory requirements into product development and commercialization processes.
- Prepare and compile regulatory submissions for market clearance, including 510(k)s, Pre-Market Approvals (PMA), Technical Files, and Design Dossiers, in alignment with FDA, EU MDR, and other international regulations.
- Support the regulatory assessment of new product concepts and modifications, providing guidance on regulatory pathways and requirements.
- Monitor and analyze changes in global medical device regulations, assess their impact on company products, and recommend necessary actions to maintain compliance.
- Assist in preparing and reviewing labeling, promotional materials, and documentation to ensure they meet regulatory standards.
- Contribute to the maintenance and accuracy of regulatory documentation, records, and databases to facilitate audits and reviews.
- Collaborate with external partners, notified bodies, and regulatory authorities during audits, inspections, and submissions.
- Contribute to post-market surveillance activities, including adverse event reporting, complaint handling, and regulatory reporting obligations.
- Assist in managing regulatory timelines and project schedules to ensure timely submissions and compliance.
- Participate in the evaluation of potential acquisitions or partnerships from a regulatory perspective.

**Qualifications**:

- Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
- 1+ years of experience in medical device regulatory affairs, including a solid understanding of FDA regulations (21 CFR Part 820), EU MDR, ISO 13485, and other relevant global medical device regulations.
- Experience with regulatory submissions, including 510(k)s, PMAs, CE Marking, and other international registrations.
- Strong analytical and problem-solving skills with attention to detail and accuracy.
- Excellent communication skills for effective collaboration across teams and interactions with regulatory agencies.
- Proficiency in regulatory affairs software, documentation systems, and Microsoft Office Suite.
- Ability to work independently and prioritize tasks in a fast-paced environment.
- Enthusiastic and adaptable with a continuous improvement mindset.

**Join Our Team**:If you are a dedicated and proactive individual with a background in medical device regulatory affairs and a passion for ensuring product compliance and patient safety, we encourage you to apply. Your contributions will be instrumental in advancing our mission of transforming healthcare through innovation and regulatory excellence.

To apply, please submit your resume and a cover letter detailing your relevant experience and achievements in medical device regulatory affairs.

**Job Types**: Full-time, Permanent

**Salary**: ₹300,000.00 - ₹1,000,000.00 per year

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Application Question(s):
**Experience**:

- medical device regulatory: 3 years (required)

  • Medical Device Regulatory Affairs Executive

    1 week ago

    Dehra Dun, India Sunfox technologies Pvt Ltd Full time

    **Company Overview**: **Sunfox Technologies** is a forward-thinking and innovative medical device company committed to revolutionizing healthcare through advanced technologies. We are seeking a talented and motivated Medical Device Regulatory Affairs Executive to play a vital role in ensuring regulatory compliance for our cutting-edge medical devices. If you...

  • Regulatory Affairs Associate

    3 weeks ago

    Dehra Dun, India Sunfox Technologies private limited Full time

    **Job description** Roles and Responsibilities: - Reviewing and interpreting regulatory requirements for medical devices and providing guidance to other departments on compliance issues. - Collaborating with other departments, such as research and development, quality, and manufacturing, to ensure that products meet regulatory requirements. - Staying...

  • Dra Officer

    3 weeks ago

    Dehra Dun, India Sanidhya Sansar Ventures Full time

    **Position**: Drug Regulatory Affairs (DRA) Officer for Non Parenteral Pharma Company. - **Responsibilities**: Ensure regulatory compliance, prepare and submit regulatory documents, and collaborate with regulatory agencies. - **Qualifications**: Bachelor's degree in Pharmacy or related field, with minimum 2 years of pharmaceutical regulatory affairs...

  • Drugs Regulatory Affairs Executive

    7 days ago

    Dehra Dūn, Uttarakhand, India HireExcel Solution Full time

    Must know Preparation of dossier. Compile and maintain regulatory documentation databases or systems. Coordinate efforts associated with the preparation of regulatory documents or submissions.Job Types: Full-time, Regular / PermanentSalary: Up to ₹50,000.00 per monthBenefits: Health insurance Paid sick time Provident FundSchedule: Day shiftSupplemental pay...

  • Regulatory Compllance Executive(Export)

    3 weeks ago

    Dehra Dun, India Nutricare Life Sciences Ltd. Full time

    Regulatory Compliance: Stay up-to-date with changes in export regulations and trade laws to ensure the company's adherence to international trade compliance standards.Documentation Management: Oversee the preparation, review, and submission of all necessary export documentation, including but not limited to export licenses, certificates of origin, and...

  • Personal Assistant

    2 weeks ago

    Dehra Dun, India WalkTalk Radio Full time

    Responsibilities: - Manage the Director's calendar, scheduling appointments, meetings, and events while optimizing time efficiency. - Coordinate travel arrangements, including flights, accommodations, and transportation. - Prepare and edit documents, presentations, and reports as required. - Conduct research and compile information for various projects and...

  • International Admissions Officer

    7 days ago

    Dehra Dun, India Southern Academy of Business and Technology (SABT) - Adelaide Campus Full time

    **International Admissions Officer - Australian Higher Education Institution** **Job duties and respsonsibilities**: 1. International Student Recruitment: Develop and implement strategies to attract and recruit a diverse pool of international students to the institution. This may involve collaborating with marketing teams, attending international education...

  • Script Writer

    2 weeks ago

    Dehra Dun, India STUDIO UNDERGROUND Full time

    **Scriptwriter** **Location**: Dehradun, India (Relocation required) **Experience**: 3 years **Age Range**: N/A **Salary Range**: INR 20,000 - 30,000 **Company**: Studio Underground **About Us**: Studio Underground is the pulse of national-level film production, specializing in TV spots, documentaries, and narrative films. As a government film...

  • Regulatory Compllance Executive(Export)

    7 days ago

    Dehra Dūn, Uttarakhand, India Nutricare Life Sciences Ltd. Full time

    Regulatory Compliance: Stay up-to-date with changes in export regulations and trade laws to ensure the company's adherence to international trade compliance standardsDocumentation Management:Oversee the preparation, review, and submission of all necessary export documentation, including but not limited to export licenses, certificates of origin, and customs...

  • Bank Executive

    2 months ago

    Dehra Dun, India JustHR Full time

    Job Responsibility - Identify and understand the financial needs of the customers and provide suitable solutions from the array of products and services - Contribute to branch profitability by meeting sales targets - Acquire new customers and cross-selling of liability, assets and third party products to existing customers - Enhance existing relationship...

  • Associate Dean of Academic and Student Success

    3 weeks ago

    Dehra Dun, India Exeed College Full time

    **Associate Dean of Academic and Student Success**: **Responsibilities**: - Oversees the strategic planning process for all educational programs. - Collaborates with university faculty and staff for program development. - Assists with the implementation and evaluation of academic programs. - Collaborates with other faculty and staff in the identification...

  • Executive Site Inspectordehradun

    2 months ago

    Dehra Dun, India Reliance Retail Full time

    **Posted Date** - 13 Feb, 2023**Business** - Electronics Prod. Bus. Group**Family** - Quality Management**Functional Business Area** - Quality**Location** - Dehradun**Responsibilities**: "- Schedule factory audits & release the audit report - Prepare improvement area against the report & share with suppliers - Search appoint 3rd party inspection, testing...

  • General Surgeon

    2 months ago

    Dehra Dun, India Team Spirit HR Solutions Full time

    Dear Doctor's Details of the Vacancies are as below: - Job Location: - Dehradun Uttarakhand Qualification: -General Surgeon. Experience: - 2 to 4 Years Package: - 3.30 to 3.90 Pm. **ACCOMMODATION WILL ALSO B PROVIDED FROM HOSPITAL END.** **Job description** **Roles and Responsibilities** - Examining patients and making diagnoses to determine the...

  • Senior Analyst, SAP Security

    3 weeks ago

    Dehra Dun, India Sony Pictures Full time

    We currently have an opportunity available in India for a Senior Analyst in our SAP Security team (part of IT Compliance Enablement).This role will provide technical operational support across our global SAP suite of applications including but not limited to: SAP S4HANA, SAP BW4HANA, BPC, SAP Fiori, and SAP Access Control Suite v12, Concur, and...

  • commercial data governance lead

    7 days ago

    Dehra Dūn, Uttarakhand, India Argenx Full time

    Commercial Data Governance LeadFor the expansion of our Business Information Systems (BIS) team, argenx is looking for a Data Governance Lead with focus on the Commercial and Medical Affairs functions.The Data Governance Lead establishes, deploys, and enforces the policies and procedures for end-to-end data governance to ensure data is used and maintained...

  • commercial data governance lead

    7 days ago

    Dehra Dūn, Uttarakhand, India Argenx Full time

    Commercial Data Governance Lead For the expansion of our Business Information Systems (BIS) team, argenx is looking for a Data Governance Lead with focus on the Commercial and Medical Affairs functions. The Data Governance Lead establishes, deploys, and enforces the policies and procedures for end-to-end data governance to ensure data is used and...

  • Officer Quality control

    7 days ago

    Dehra Dūn, Uttarakhand, India Avantor Full time

    The Opportunity: . Officer – QC is responsible for maintaining the Quality of the products and procedures for Diagnostics and to ensure that the business achieves its targets and growth rate. What we're looking for: Education: Graduate/ Post-graduate in Life Sciences (preference to Biotechnology and Biochemistry) Experience: 1-3 years of...

  • Officer Quality control

    7 days ago

    Dehra Dūn, Uttarakhand, India Avantor Full time

    The Opportunity:Officer – QC is responsible for maintaining the Quality of the products and procedures for Diagnostics and to ensure that the business achieves its targets and growth rateWhat we're looking for:Education:Graduate/ Post-graduate in Life Sciences (preference to Biotechnology and Biochemistry)Experience:1-3 years of experience Diagnostic...

  • Senior Account Executive

    7 days ago

    Dehra Dūn, Uttarakhand, India Incode Full time

    REIMAGINE TRUST Incode is the leading provider of world-class identity solutions that is reinventing the way humans authenticate and verify their identities online to power a world of digital trust. Through our revolutionary identity solutions, we are unleashing the business potential of universal industries including finance, government, retail,...

  • BigShip - Manager - Investor Relations

    7 days ago

    Dehra Dūn, Uttarakhand, India Bigship Technologies Full time

    Investor Relations Manager Are you a dynamic financial professional with a passion for building investor confidence and communicating strategic growth? Do you thrive in a fast-paced startup environment where your contributions make a direct impact? If so, we want you on our team at Bigship Technologies Pvt. Ltd.At Bigship Technologies Pvt. Ltd., we are...