Regulatory Affairs Executive

Title/Designation: Executive
- Regulatory Affairs

Reports to: RA Manager

Based at: Ahmedabad

Industry: class III Medical Device

Qualification : B.pharm, M.pharm or Msc

Job description

An exciting opportunity to work for class III / Class -D medical device certification & regulations

Key responsibilities/ accountabilities:
For the above position, your roles and responsibilities would include:

- To assist in new products registration and license renewal compliance to local regulations, as well as GMP, CE and ISO 13485 requirement.
- To assist the QA/RA team and ensure quality and good standard operating procedures within the company.
- Have the joint responsibility to develop, facilitate and execute comprehensive regulatory strategies through all phases of development and product life cycle, to accelerate and ensure successful product registrations and provides regulatory assessment and supports Change Control Assessment.
- Oversee the maintenance of product quality and compliance through the Quality Assurance and Quality Control functions as well as management of the Quality Management System and compliance processes.
- Support Commercial Department in business development such as product evaluation and pre-launch activities.
- Keep abreast of international legislation and guidelines of current product line in India.
- Compliance with respect to internal/external audits meeting regulatory/ accreditation requirements.
- Reviewing current accreditation/regulatory requirement, performing gap analysis and ensuring compliance to current requirements
- Provide product specific Regulatory strategies to mitigate risk; works in conjunction with production & QA team to provide advice on process and labeling changes.
- Review of SOPs, BPRs, specifications and change control to ensure compliance.
- Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
- Drives resolution of issues. Communicates issues, impact and outcomes to the management team.
- Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects.
- Responsible for ensuring compliance to the submission standards, procedures and policies in India.

Profile
- Minimum 0 to 04 years of experience in regulatory affairs and quality assurance in the medical device industry
- Bachelor's degree in relevant field. Master’s is desirable.
- Ethical behavior and high level of integrity.
- Good team work, independent and committed to works across functional departments
- Possess good negotiation and dispute resolution skills.
- Demonstrated experience operating in a regulated environment.
- Demonstrated knowledge of regulatory issues, and experience interfacing with local regulatory bodies.
- Ability to read, analyze, and interpret governmental regulations & reports, scientific or clinical publications and data
- Ability to write reports, business correspondence, and quality procedures.
- Must be able to effectively operate in a PC environment, be familiar with Microsoft Word, Excel, PowerPoint, Access, Outlook and Internet data search utilities.

Desired Skills and Experience
- class III Medical Device ,Regulatory Affairs, Quality Assurance.

**Salary**: ₹300,000.00 - ₹550,000.00 per year

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Ability to commute/relocate:

- Moraiya, Changodar, Ahmedabad - 382213, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- Medical Device or pharmaceutical: 3 years (preferred)