Tata Elxsi works with leading medical device OEMs and technology companies for market research and human factor engineering, hardware and software engineering, verification & validation, regulatory standards & compliance requirements along with technologies such as artificial intelligence, cloud and IoT. Tata Elxsi’s Medical Device and Healthcare practice is ISO 13485 certified.
Post : Regulatory Affairs Specialist - Tata Elxsi
Job Summary
This position is to support the MDR project and requires an advanced understanding of medical device products as well as an understanding of the European Union Medical Device Directive and Medical Device Regulations and regulatory submissions process.
Job Description
Principal Duties and Responsibilities
• Assist with assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process; including the regulatory submissions process. Authors and publishes electronic submissions
• Interprets and applies EU regulations and provides regulatory input, advice, and guidance to the organization and design teams
• Researches, analyzes and communicates information pertaining to the appropriate regulatory pathway for new or modified products. Interprets results of research
• Reviews proposed labeling for compliance with applicable EU regulations
• Writes, manages, and approves the development of package inserts
• Reviews proposed product changes for impact on regulatory status of the product
• Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates, as required due to MDR changes
• Provides regulatory direction to development project teams as a core team member;
• Evaluates risk of proposed regulatory strategies and offers solutions
Expected Areas of Competence (i.e., knowledge, skills and abilities)
• Demonstrated strong writing and communication skills
• Strong interpersonal skills and attention to detail
• Ability to manage several competing priorities; versatility, flexibility, and willingness to work with changing priorities
• Proficient knowledge of overall business environment, the orthopaedic industry and the marketplace
• Mastery of relevant regulations pertinent to medical devices and biologics, as applicable
• Ability to function well as a member of the team and build relationships between Regulatory Affairs and other areas of the organization
• Able to identify risk in regulatory strategies
• Advanced anatomic knowledge
• Proven analytical and negotiation skills
• Experience with solving problems and concerns
• Intermediate computer skills, including Microsoft Office Suite
• Ability to lead a team and influence others
• Proficient knowledge of EU regulations (including labeling regulations) and regulations outside of the EU
Candidate Profile
• Technical / engineering degree, life sciences or related field preferred. Alternate degrees may be considered.
• Has authored technical file submissions and has hands on experience with Essential Requirement Checklists (ERCs) or General Safety and Performance Requirements (GSPRs).
• Moderate to deep understanding of design controls and risk management, is preferable.
• A minimum of 6-10 years of experience in Regulatory Affairs required
• A minimum of 3-6 years of experience in orthopaedic or medical device industry preferred
• A combination of experience in biological products, and medical device products preferred
• A combination of education, experience, leadership, strategy and RA influence may be considered
Additional Information
Experience : 6-10 years
Qualification : B.E / B.Tech / B.Pharm / M.Pharm / PharmD / PhD
Location : Pune
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th December, 2021
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