Clinical & Regulatory Executive

3 days ago

New Delhi, India BIOTRONIK Full time

BIOTRONIK is one of the leading manufacturers of cardio
- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

**Position: Clinical & Regulatory Executive**

**Country:
India

**Location**:
New Delhi

**Business Entity**:
BIOTRONIK

**Department**:
Marketing

**Position Reports to**:
Marketing Manager

**Status:
Individual Contributor

**Main Responsibilities**:

- Provide in-depth knowledge and experience with medical device registration requirements.
- Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries.
- Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017.
- Coordinating regulatory documentation activities and provide technical review of data or reports.
- Identify and interpret relevant regulatory guidelines.
- Maintain Quality/Product Complaint data in information systems or databases with timely submission to authorities.
- Coordinate the communication on clinical trials between the participating site and HQ Clinical team.
- Timely submission of update to HQ clinical team.
- Documentation of clinical contract/milestones and reimbursement to the clinical sites based on the milestone achievements
- Evaluate applicable laws and regulations to determine impact on company activities.
- Advise on regulatory and compliance matters.
- Ensure compliance according to regulation guidelines.

**Education & Experience**:

- Graduate of Science / Biomedical Engineer.
- Minimum 2 years’ experience in the regulatory dossier submission & query handling to DCGI.
- Work in a medical device or diagnostics industry.
- Has clinical study / trial handling experience.
- Support regulatory submission for South Asia countries.

**Skills**:

- Be flexible to prioritize work based on urgency and importance.
- Ability to develop and maintain positive business relationships.
- Foster an environment of mutual respect, understanding, trust, and support.
- Anticipate and respond to the needs of stakeholders (e.g., internal and external customers, etc.) in a timely manner.
- Convey clear, concise information in verbal, written, electronic, and other communication formats.
- Demonstrate active listening while engaging others.

Location: New Delhi | Type of contract: Full time permanent

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