Regulatory Affairs Specialist

6 years

Not Disclosed

Bangalore

15 June 5, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Work Shift:

DAY

Work Schedule:

Why Merit?

At Merit Medical, our mission is to create innovative medical devices that improve lives. Our goal is to hire and develop people who want to build something special through hard work, team effort, and commitment. Together, we are making a difference in the lives of patients around the world.

ESSENTIAL FUNCTIONS PERFORMED

1.   Coordinates and prepares document packages for:
•   Regulatory submissions (domestic and international)
•   Facilitates corrective actions on internal audits
•   Governmental inspections
•   Recalls
•   Medical Device Reports
•   Clinical trials
•   Company policies and procedures
2.   Interacts, as directed, with various levels of management, external agencies and companies.
3.   Participates on project task teams.
4.   Performs other related duties and tasks, as required.

ESSENTIAL PHYSICAL/ENVIRONMENTAL DEMANDS

•   Lifting -- Not to exceed 50 lbs – local practice may apply.
•   Writing
•   Sitting
•   Standing
•   Bending
•   Visual acuity
•   Color perception
•   Depth perception
•   Reading
•   Field of vision/peripheral

SUMMARY OF MINIMUM QUALIFICATIONS

•   Education and/or experience equivalent to a Bachelor's Degree and two years of related experience or six years of regulatory experience.
•   Demonstrated knowledge of regulatory affairs.
•   Demonstrated human relations and effective communication skills.
•   Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.
•   Strong organizational skills and the ability to be self-motivated and be detailed oriented.

COMPETENCIES

•   Document packaging and coordination for:
•   Regulatory submissions (domestic and international)
•   Facilitates corrective actions on internal audits
•   Governmental inspections
•   Recalls
•   Medical Device Reports
•   Clinical trials
•   Company policies and procedures
•   Management/external agency/company interaction.
•   Project task team participation

COMMENTS

Infectious Control Risk Category III:

The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.

As an eligible Merit employee, you can expect the following:

* Multiple Shifts and Hours to choose from: Days, Swing (Eve), and Nights

* Medical/Dental & Other Insurances (eligible the first of month after 30 days)

* Low Cost Onsite Medical Clinic

* Two (2) Onsite Cafeterias

* Employee Garden | Gardening Classes

* 3 Weeks' Vacation | 1 Week Sick-Time | Paid Holidays

* 401K | Health Savings Account

To see more on our culture, go to www.merit.com/careers.

Military Veterans are encouraged to Apply.

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