About This Career Path
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.
Government & Public Administration
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
Regulatory Affairs Specialists
Average
$67,680
ANNUAL
$32.54
HOURLY
Entry Level
$38,170
ANNUAL
$18.35
HOURLY
Mid Level
$62,470
ANNUAL
$30.04
HOURLY
Expert Level
$101,760
ANNUAL
$48.92
HOURLY
Regulatory Affairs Specialists
Regulatory Affairs Specialists
Supporting Certifications
Degree Recommendations
Regulatory Affairs Specialists
01
Coordinate efforts associated with the preparation of regulatory documents or submissions.
02
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
03
Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
04
Coordinate, prepare, or review regulatory submissions for domestic or international projects.
05
Prepare or maintain technical files as necessary to obtain and sustain product approval.
06
Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
07
Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
08
Coordinate recall or market withdrawal activities as necessary.
09
Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
10
Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
Regulatory Affairs Specialists
Common knowledge, skills & abilities needed to get a foot in the door.
KNOWLEDGE
English Language
KNOWLEDGE
Law and Government
KNOWLEDGE
Biology
KNOWLEDGE
Computers and Electronics
KNOWLEDGE
Administration and Management
SKILL
Active Listening
SKILL
Speaking
SKILL
Writing
SKILL
Critical Thinking
SKILL
Judgment and Decision Making
ABILITY
Written Comprehension
ABILITY
Written Expression
ABILITY
Oral Comprehension
ABILITY
Oral Expression
ABILITY
Deductive Reasoning
Regulatory Affairs Specialists
Senior Regulatory Affairs Specialist - 2406173183W
**Description**
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. _Remote work options may be considered on a case-by-case basis and if approved by the Company_
Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives. Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians. Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before. Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.
The Senior Regulatory Affairs Specialist will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices. You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period. Through your engagement in this role, you will help shape the life-saving field of heart recovery.
**The ideal candidate will:**
* Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices
* Be energized by joining a world-class company and regulatory team
* Enjoy teamwork and thrive as a member of dynamic cross-functional teams
* Build and maintain strong interpersonal relationships within and outside of the company
* Exhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering results
* Adaptable and thrive in a dynamic work environment where variety is the routine.
* Embrace change, continuous learning, and work skills improvement
**Key Responsibilities:**
* Support cross-functional new product development projects and lead compilation of all materials required for submissions to FDA
* Provide ongoing support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations
* Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance
* Provide support for changes to existing products, including providing regulatory assessment of changes, and subsequent regulatory filings
* Develop solutions to a variety of technical problems. Actively participate in problem solving discussions and recommend solutions
* Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies
* Assist in the maintenance and improvement of regulatory SOPs
* Interact and negotiate with regulatory agencies on defined matters as needed
**Qualifications**
**Education**
* Degree in engineering or science required
* Advanced degree is preferred
**Required**
* Minimum of 4 years with a Bachelor's degree or Minimum of 3 years with an advanced degree
* Regulatory affairs experience in the medical device industry with a track record of successful submissions
* Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance
* History of successful IDE/PMA/510(k) device submissions (Class III device submissions preferred)
* Experience supporting software device development (for example SiMD, SaMD, AI, Cybersecurity, IEC 62304/82304 etc)
* Experience with FDA requirements, guidance documents, ISO 14971, ISO 13485, IEC 60601, IEC 62304
* Ability to effectively manage multiple projects and priorities
* Strong communication and regulatory writing skills
* Strong problem solving skills, interpersonal skills and effective team member
* Results oriented. Ability to drive to completion in adherence to aggressive project schedules
**Preferred**
* Ability to comprehend principles of engineering, physiology and medical device use. Cardiovascular device experience
* Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
**Other**
* Travel up to 10%
* Must be able to effectively work remotely
This job posting is anticipated to close on 3.20.2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
For U.S. applicants, in accordance with applicable disclosure requirements, the anticipated base pay range for this position is $104,000 to $140,000. The Company maintains highly competitive, performance-based compensation programs. . Additional information can be found through the link below. For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
**Primary Location** NA-US-4887-Danvers
**Other Locations** NA-United States
**Organization** ABIOMED Inc.(6942)
**Job Function** Regulatory Affairs
**Req ID:** 2406173183W
Full Time
Government & Public Administration
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