Regulatory Affairs Specialist – Medical Devices

Company Description

Alpine Health is a licensed pharmaceutical distributor based in Secaucus, New Jersey, USA. We

serve independent pharmacies across the US. Alpine Health offers a full range of generics,OTC's, diabetic supplies, vials and nutritional milk.The organization is in business in the USA market since 2008 and is now expanding its reach of partnering with companies worldwide to introduce high quality medical devices in markets

worldwide.

Job Description

Overview :

This is an opportunity to work in a key role with a broad spectrum of responsibilities in a

growing healthcare company that has expanded in various domains in the industry and to

contribute to the growth of the company. The vision is to build strong medical device portfolio

in the regulated markets across the world, where the regulatory function plays a crucial role in

this development. The Regulatory Affairs Specialist reports to the site head in India.

The work is with domestic and international focus and performed in close cooperation with

several international development partners and manufacturers

Roles & Responsibilities :

 The individual will be working on regulatory requirement of Medical devices and

Distribution in various markets

 Coordinate successful submissions and approval of all medical device approval

applications with various regulatory authorities worldwide

 Keep up-to-date with changes in regulatory legislation and guidelines for medical

devices across various markets

 Write comprehensible, user-friendly, clear product information leaflets and labels

 Review and report overall quality status to the management team

 Use a variety of specialist computer applications

 Explain regulations, policies, or procedures for medical device fillings

 Maintain data 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.

Regulatory Affairs Specialist – Medical Devices

___________________________________________________

 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 :

 Thorough 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.

Education

Master of Public Administration (MPA), Bachelor of Interdisciplinary Studies, Master of Accounting, Doctor of Dental Surgery / Medicine (DDS / DMD), Bachelor in General Studies (BGS), Bachelor of Health Science, Doctor of Audiology (AuD), Doctor of Ministry, Doctor of Public Health (DrPH), Doctor of Veterinary Medicine (DVM), Master of Divinity, Master of Social Work (M.S.W), Masters in Arts (M.A), Doctor of Nursing Practice (DNP), Bachelor of Arts (B.A), Master of Music (MM / MMus), Master of Professional Accountancy (MPA), Master of Tax Accounting, Master of Public Health (MPH), Master of Library & Information Science (MLIS), Masters in Technology (M.Tech / M.E), Doctor of Pharmacy (PharmD), Bachelor of Applied Science (BAS), Doctor of Business Administration (DBA), Bachelor of Commerce (B.Com), Master of Fine Arts (MFA), Master of Health Science (MHSc), Doctor of Education, Bachelor Of Technology (B.Tech / B.E), Doctor of Physical Therapy, Bachelor of Science (B.Sc), Master of Technical & Professional Communication, Master of Law (M.L / L.L.M), Bachelor Of Pharmacy (B.Pharm), MBBS, Doctor of Science (DSc / ScD), Master of Pharmacy (M.Pharm), Bachelor of Architecture (B.Arch), Bachelor of Homeopathic Medicine and Surgery (BHMS), Master of Library Science, Bachelor of Ayurvedic Medicine and Surgery (BAMS), Doctor of Jurisprudence, Doctor of Psychology (Psy. D. / D. Psych.), Master of Real Estate Development, Master of Natural Resources (MNR), Doctor of Medicine (M.D / M.S), Doctor of Optometry, Bachelors of Law (B.L / L.L.B), Bachelor Of Computer Application (B.C.A), Master of Education (M.Ed), Masters in Communications Disorders (MCD), Doctor of Musical Arts (DMA), Bachelor of Music, Masters of Architecture (M.Arch), Master in Landscape Architecture, Master of Planning (M.Plan), Doctor of Chiropractic (DC), Master of Commerce (M.Com), Bachelor of Business Administration (B.B.A), Bachelor of Social Work (B.S.W), Master of Health Administration (MHA), Bachelor of Education (B.Ed), Bachelor in Hotel Management (B.H.M), Bachelor of Dental Surgery (B.D.S), Master in Computer Application (M.C.A), Master OF Business Administration (M.B.A), Bachelor of Liberal Arts (BLA / ALB), Master of Liberal Arts (MLA / ALM), Bachelor of Music Education (B.M.E.)

Skills Required

Regulatory, Regulatory Affairs