Regulatory Affairs Executive Medical Device

4 weeks ago

Pimpri, India OPERON STRATEGIST Full time

**Regulatory Affairs Specialist**

Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards. Assist in creation and maintenance of regulatory files.

**Duties and Responsibilities**

As a regulatory affairs officer, you'll need to:

- ensure that a company's products comply with the regulations of the regions where they want to distribute them
- keep up to date with national and international legislation, guidelines and customer practices
- collect, collate and evaluate scientific data from a range of sources
- develop and write clear arguments and explanations for new product licences and licence renewals
- prepare submissions of licence variations and renewals to strict deadlines
- monitor and set timelines for licence variations and renewal approvals
- work with specialist computer software and resources
- write clear, accessible product labels and patient information leaflets
- plan and develop product trials and interpret trial data
- advise scientists and manufacturers on regulatory requirements
- provide strategic advice to senior management throughout the development of a new product
- project manage teams of colleagues involved with the development of new products
- undertake and manage regulatory inspections
- review company practices and provide advice on changes to systems
- liaise with, and make presentations to, regulatory authorities
- negotiate with regulatory authorities for marketing authorisation
- take part in the development of marketing concepts and approve packaging and advertising before a product's release.

2. Assist in preparing response to regulatory authorities' questions within assigned timelines.

3. Stay abreast of regulatory procedures and changes in regulatory climate.

4. Assess device related incidents/complaints for medical device reporting requirements. Compile and submit reportable events to relevant regulatory authorities in timely manner. Handle recalls and field actions, if required.

5. Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.

6. Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.

7. Other duties as assigned.

**About Operon Strategist**:
We provide turnkey services spanning from product design and development, and manufacturing unit design up to achieving regulatory approvals at the national as well as international levels.

We are medical device regulatory services and provide worldwide support to health industry service providers.

**Salary**: ₹180,000.00 - ₹240,000.00 per year

**Benefits**:

- Health insurance

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Pimpri Chinchwad, Pimpri - 411019, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- Medical Device Regulation: 2 years (required)

**Speak with the employer**
+91 7822919196
Application Deadline: 19/07/2023
Expected Start Date: 20/07/2023

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