Regulatory Affairs Specialist jobs in West Bloomfield, MI

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

A
EMEA Regulatory Affairs Specialist
  • Actalent
  • Detroit, MI OTHER
  • Description:

    The Regulatory Affairs Specialist is responsible for implementing global product Regulatory strategies and processes focused on ensuring compliant, timely, and cost-effective submissions to get needed licenses, registrations, and listings for medical devices and drugs.

    Key Responsibilities:

    • Lead timely execution of Regulatory submission activities required to secure global market clearances, registrations and licenses for medical device and drug products

    • Assist with providing leadership to global business in the preparation of regulatory submission documents and activities required to secure global licenses, registrations and listings in a timely and cost-effective manner

    • Assist with the development of effective long and short-term Regulatory product strategies by closely working with global Sales/Marketing and Product Development teams on pipeline medical device and drug international registrations

    • Ensure accuracy of Declaration of Conformity for EU in conjunction with Authorized Representative and provide support for medical device and drug classification in global markets

    • Review product and labeling/claims changes to maintain regulatory compliance

    • Maintain regulatory records by updating corporate databases, recording and filing appropriate regulatory registrations and submissions

    • Ensure product labeling and claims are accurate, substantiated, documented, and compliant with applicable regulations

    • Oversee and maintain site establishment registrations and certifications

    • Monitor domestic and international regulatory development changes that may potentially impact the company’s products and operations, and provide proactive interpretative analysis of regulations, directives and guidance for required actions

    • Provide education and training on regulations to company employees, as needed

    • Investigate and report to global regulatory authorities (as required) product complaints

    Additional Skills & Qualifications:

    • At a minimum, completion of a Bachelor's (e.g. Life/Physical Science, Engineering, Business, etc.) is required. Additional training in regulatory affairs, quality assurance, project management, risk management, etc. is strongly preferred. Advance degree is also strongly preferred.
    • An experienced regulatory professional with 5 years of medical devices and associated regulatory experience
    • 5 years of experience developing and successfully defending complex regulatory submissions for medical devices and drugs
    • Proven experience building effective relationships with the FDA and other international regulatory bodies including the EU and Health Canada
    • Experience with submitting Adverse Events/Vigilance reports to applicable global regulatory bodies
    • Strong knowledge of global country-specific regulations required for registering and marketing products for sale in applicable countries
    • Understanding of FDA 21 CFR Part 201, 210, 211, 803, 806, & 820, ISO 14971 and ISO13485 regulatory/quality standards
    • Must have excellent written and spoken English
    • Excellent communication and organizational skills

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

    Diversity, Equity & Inclusion

    At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

    • Hiring diverse talent
    • Maintaining an inclusive environment through persistent self-reflection
    • Building a culture of care, engagement, and recognition with clear outcomes
    • Ensuring growth opportunities for our people

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

  • 12 Days Ago

A
Product Safety and Regulatory Affairs Specialist, Automotive and Specialty Coatings
  • AkzoNobel
  • Troy, MI FULL_TIME
  • We’ve been pioneering a world of possibilities to bring surfaces to life for well over years. As experts in making coatings, there’s a good chance you’re only ever a few meters away from one of our pr...
  • 2 Days Ago

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Detroit, MI FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

B
Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Warren, MI FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

E
Regulatory Compliance Specialist
  • Evolution Americas
  • Southfield, MI FULL_TIME
  • Company Description Evolution is a developer and supplier of virtual casino games, since 2006. We evolve the gaming industry by designing and hosting the most streamed, interactive casino tables and s...
  • 9 Days Ago

S
Government Affairs Specialist II
  • Southeast Michigan Council of Governments
  • Detroit, MI FULL_TIME
  • First Review of Applications: Tuesday, April 2, 2024 (open until filled) Role and Responsibilities SEMCOG (EOE) is seeking an outgoing and experienced Government Affairs Specialist II to join the Gove...
  • 9 Days Ago

Filters

Clear All

Filter Jobs By Location
  • Filter Jobs by companies
  • More

0 Regulatory Affairs Specialist jobs found in West Bloomfield, MI area

H
Sr. Revenue Integrity Analyst Full Time Hybrid
  • Henry Ford Health System
  • Troy, MI
  • GENERAL SUMMARY: Reporting to the Manager, Revenue Integrity, Revenue Integrity Senior Analyst has an important role in ...
  • 3/28/2024 12:00:00 AM

T
Senior Financial Analyst 115k
  • Tier 1 Automotive Supplier
  • Troy, MI
  • Bill Watts at Robert Half is working with a global Tier automotive supplier who is looking to add a new Senior Financial...
  • 3/28/2024 12:00:00 AM

S
Director of Finance
  • Secure Financial Group
  • Troy, MI
  • Job Description Job Description About Secure Financial Group: Secure Financial Group is a leading financial services fir...
  • 3/28/2024 12:00:00 AM

P
Director of Treasury
  • Presbyterian Villages of Michigan
  • Southfield, MI
  • Overview: Presbyterian Villages of Michigan, a premier senior living and services faith-based non-profit organization, i...
  • 3/27/2024 12:00:00 AM

M
Assistant Branch Manager
  • Michigan First Credit Union
  • Troy, MI
  • Location : Address: 2001 W Maple Rd Location : City: Troy Location : Postal Code: 48084 Responsibilities: Location This ...
  • 3/26/2024 12:00:00 AM

A
Financial Analyst
  • ABC Technologies
  • Southfield, MI
  • The Engineering and IT Controllership plays a crucial role in ensuring financial discipline and accountability within en...
  • 3/25/2024 12:00:00 AM

M
Assistant Branch Manager
  • Michigan First Credit Union
  • Sterling Heights, MI
  • Location : Address: 33201 Van Dyke Ave Location : City: Sterling Heights Location : Postal Code: 48312 Responsibilities:...
  • 3/25/2024 12:00:00 AM

B
Instrument Assembler
  • Bio-Rad Laboratories, Inc.
  • Ann Arbor, MI
  • **Instrument Assembler** ** Instrument Assembler** * 2022-26894 * Hercules, California, United States Bio-Rad is looking...
  • 3/24/2024 12:00:00 AM

West Bloomfield is sometimes referred to by its residents as the "lake township of Oakland County", being heavily dotted with small and medium-sized lakes. Cass Lake, the largest lake in the county, is in part of West Bloomfield, and Pine Lake, which has a private country club on its shore, is only a few miles away from Cass and lies completely within West Bloomfield. In addition, directly west of Pine Lake is Orchard Lake, which also has a private country club on its shore. Orchard Lake is surrounded by the city of Orchard Lake Village. Several smaller lakes are scattered around these larger...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$76,710 to $102,802
West Bloomfield, Michigan area prices
were up 1.2% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020