PerkinElmer jobs - Regulatory Affairs Specialist

Regulatory Affairs Specialist

PerkinElmer
experience 1 Year
salary Salary not disclosed
qualification
Read More...
Posted: 2 Months ago
share this job
save job
Job is expired

Job Description

Key Responsibilities
Support preparation and timely completion of FDA submissions for in vitro diagnostic devices (assays, instruments, software) to meet project and business needs (Pre-Submission, 510(k),de Novo, PMA supplement, PMA annual report, etc.)
Participation on cross functional project teams to provide strategic and tactical guidance to meet US FDA requirements,
Support development of regulatory strategy for US submission and/or global regulatory plans for US manufactured IVD products
Assessment and applicable documentation of changes in product, manufacturing processes, labeling affecting IVD products distributed in the US, including communication to global Regulatory and project teams for impact assessment
Support global Regulatory teams and/or in-country dealers/representatives with regulatory registrations of US manufactured IVD products
Maintain up-to-date knowledge of US IVD regulations and applicable guidance’s, monitor development of regulations and communicate impact to the business
Support CE marking activities for US manufactured IVD products
Support day-to-day activities of the Regulatory Product Release system (product classification, set up of licences, release of orders, etc.)

Qualifications: 
Bachelor’s degree in life science related field (Medical Technology, Clinical Chemistry, Biology)
Minimum of 1 years of experience supporting FDA submissions for IVD and/or medical devices
Understanding of FDA regulations and guidance documents required
Previous experience supporting international registrations
Limited travel (up to 10-15% of the time, or as circumstances dictate)
Good interpersonal, verbal and written communication skills (in English)
Excellent time management, organizational, negotiation, and problem solving skills
Ability to work independently

VIEW MORE

Job Particulars

Role HR
Job TypeApprenticeship
Hiring Process Face to Face Interview

About Company

PerkinElmer
Similar Jobs
experience 1 Year
locationMumbai
salary Salary not disclosed
1 month ago
Quick Apply
left slide     right slide
Jobs By LocationVIEW ALL
Active Jobs By Role
Accountant (1799) Admin (229) Agriculture and Dairy (20) Architect (229) Bartender (0) Beauticians / Spa (135) Bouncer (1) BPO / Customer care (4056) Caretaker / Nanny (25) Carpenter (27) Cashier (5) Cleaner / Washer (47) Construction / Laborer (59) Content Writer (1225) Counsellor (249) Cook / Chef (400) Data Analytics (10) Data Entry / Back Office (1870) Design / Animation (1951) Delivery (926) Digital marketing / SEO (1752) Draughtsman/Draftsman (2) Driver (85) Doctor / Physician (135) Electrician (105) Engineer (1844) Engraver (5) Event Planner (7) Fire Fighter (11) Fitter (93) Gardener(Mali) (1) Ground Staff (429) Hospitality Executives (246) Housekeeping (182) HR (3042) Insurance Consultant (49) Lab Technician (67) IT Software-Engineer (5425) IT - Mobile Developer (602) IT Hardware Engineer (225) Language Translator (3) Legal (24) Librarian (0) Management Trainee (514) Mechanic (485) Media / Journalism (526) MIS Executive (11) Moulder (0) Nurse (158) Nutritionist / Dietician (5) Operations (136) Office Assistant / Helper (204) Operator / Machinist (216) Packager (15) Painter (6) Pharmacist / Medical Rep (207) Photographer / Videographer (36) Physiotherapist (6) Plumber (7) Research/JRF/SRF (368) Receptionist / Front Office (473) Retail / Store Executive (511) Rigger (1) Sales / Marketing (8275) Security / Guards (44) Sports Trainer (1) Tailor/ dress designer (177) Teacher (381) Tool & Die Maker (0) Tourist Guide (2) Trainer (47) Waiter / Steward (24) Ward Boy (2) Warehouse Executive (12) Welder (78) Others (2985)
safety tipsSafety Tips
Teamlease does not charge any kind of payment for a job.
get job tipsHow to get a Job early? Follow these tips

1.The more the Jobs you apply, the higher your chances of getting a job.

2. Keep your profile updated Update

Recruiters prefer candidates with complete profile information.

3. Keep visiting the Teamlease.com daily

Daily visit will ensure you won’t miss out on any Job opportunity.

4. Watch videos to improve Watch videos

Be a better candidate than others by watching these Job-related videos.

PerkinElmer recruiting Regulatory Affairs Specialist Experienced(1 Year) candidates candidates nearby Mumbai,.PerkinElmer vacancies for Regulatory Affairs Specialist is recruited through Written-test, Face to Face Interview etc.
PerkinElmer Company recruits a lot of Experienced(1 Year) candidates candidates every year based on the skills . The candidates with Diploma, B.Com, M.Com, BBA/BBM, BCA, BE/B.Tech, MBA/PGDM, BSc, MCA, ME/M.Tech, MS, MSc, PG Diploma, 12th Pass (HSE) are selected to full fill the vacancies in HR job field. The candidates nearby Mumbai, can apply for Regulatory Affairs Specialist position in PerkinElmer. All candidates should have a degree or post-graduation in the required field based on the requirement mentioned. The jobs are available in Full Time basis. When it comes to the PerkinElmer recruitment, candidates are mostly chosen for the department of HR . To learn more about the current jobs and other details, it is better to go through official site of PerkinElmer and Teamlease.com. Find the latest jobs near you and near your home. So, that you don’t need to relocate. The Teamlease.com is a leading employment portal that researches the official site of PerkinElmer and provides all the details about the current vacancies, the application process, selection process, interview test details, important dates and other information. Search and apply for the top job positions in PerkinElmer and near your city and get a secured career.