Medical Device Regulatory Affairs Specialist

1 day ago

Ahmedabad, Gujarat, India Alpine Health Full time

About Us

Alpine Health is a reputable pharmaceutical distributor based in the United States, serving independent pharmacies across the country. We offer a comprehensive range of generics, over-the-counter medications, diabetic supplies, and nutritional products.

The company has been operating in the US market since 2008 and is expanding its global presence by partnering with international companies to introduce high-quality medical devices in various markets worldwide.

Job Overview

This is an exciting opportunity to work in a key role with a broad spectrum of responsibilities in a growing healthcare company that has expanded its presence in the industry. The ideal candidate will contribute to the growth of the company by building a strong medical device portfolio in regulated markets across the world, where regulatory functions play a crucial role in this development.

The Regulatory Affairs Specialist will report to the site head in India and work closely with domestic and international partners to coordinate successful submissions and approvals of medical device applications with various regulatory authorities worldwide.

Key Responsibilities

  • The individual will be responsible for ensuring compliance with regulatory requirements of medical devices and distribution in various markets
  • Coordinate successful submissions and approval of all medical device approval applications with various regulatory authorities worldwide
  • Stay up-to-date with changes in regulatory legislation and guidelines for medical devices across various markets
  • Develop clear and concise product information leaflets and labels
  • Review and report overall quality status to the management team
  • Utilize specialist computer applications to maintain data and perform tasks
  • Explain regulations, policies, or procedures for medical device filings
  • Maintain accurate records in information systems or databases
  • Evaluate applicable laws and regulations to determine impact on company activities
  • Provide technical review of data or reports
  • Advice the operations and business team on applicable regulatory requirements, project-specific regulatory issues as assigned.
  • Act as back-up for contact with Regulatory Agencies as needed.
  • Draft cover letters for Regulatory Agency communication.
  • Assist with timely availability of submission documents and ensure that all document components are in place on time.
  • Draft and review some document content (depending on level of regulatory knowledge/expertise).
  • Understand submission details and liaise with Submission Management.
  • Review of submission documents to ensure compliance with regulatory requirements.

Desired Skills/Experience:

· Strong understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission, and maintenance

• Strong initiation and organizational skills

• Basic analytical skill and technical/scientific competence

· Attention to details and ability to appropriately assess risks and formulate risk-management strategies

· Proactive, quick learner, and independent worker able to effectively multi-task in a high-pressure environment and follow issues through to conclusion

Requirements:

  • An advanced degree (MS) is highly preferred; a minimum of a Bachelor's Degree in Bio-medical engineering is required.
  • 5+ year relevant experience in regulatory affairs and product registrations across various markets.
  • Understanding of the regulatory submission and approval process of medical devices is required.
  • Candidate must be able to work successfully within a team environment and as an individual contributor.

Compensation:

We offer a competitive salary of approximately $120,000 per annum, commensurate with experience and qualifications. This includes benefits such as health insurance, retirement plan, and paid time off.

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