Medical Device Regulatory Affairs Executive

2 weeks 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, Regular / Permanent

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

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Dehra Dun, Uttarakhand: Reliably commute or planning to relocate before starting work (required)

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

- medical device regulatory: 1 year (required)

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