CapecoralRecruiter Since 2001
the smart solution for Cape Coral jobs

Senior Regulatory Affairs Specialist

Company: Aerotek
Location: Naples
Posted on: May 3, 2021

Job Description:

As a Senior Regulatory Affairs Specialist with this well-established Class I and II orthopedic medical device company, you will be responsible for FDA and Health Canada product submissions, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues.

o Sr. Regulatory Affairs Specialist will US and Canadian Product Registrations, Will work more heavily with Canadian Product registrations

o Will for more on getting products that are already released, licensed in Canada.

o Sr. Regulatory Affairs Specialist will support well-established Orthopedic medical device company on Class I, II and III products and be heavily involved with Regulatory Strategy for new product development and existing products

o Will be regulatory advisor and provide expertise to cross-functional teams around potential product changes and developments

o Responsible for FDA and Health Canada product submissions, license renewals, periodic updates and registrations to regulatory agencies.

o You will Organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review

product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues.

o Conduct regulatory intelligence and analysis for all active projects

o Develop regulatory strategy for US active projects

o Attend product development team meetings for each project (MPI);

o Review/Approve Engineering Change Orders (ECOs)

o Collaborate with regulatory employees to route applicable Essential Requirements Checklists to product development team members, obtain feedback, and produce signed memo;

Skills/Experience:

o Must have knowledge and proven experience in developing medical device Regulatory strategy for Health Canada

o Health Canada submissions experience

o Orthopedic knowledge required (does not require experience with Orthopedic Regulatory Submissions)

About EASi:

Amazing begins here. EASi is a leading global services company specializing in engineering and sciences. For more than 35 years, EASi has delivered critical services across a range of industries, including energy and utilities, transportation, heavy equipment, consumer and industrial products, medical devices, pharmaceutical and biotechnology, as well as academic and health care research. By adapting to the constantly evolving needs of our customers, we have built specialized expertise and a multidisciplinary perspective - leveraging cutting-edge technology and processes - to constantly improve and innovate. Through EASi's flexible solutions and consultative approach, customers in engineering and sciences can expect unparalleled quality, increased speed to market and collaborative customer engagement services.

Headquartered in Hanover, Maryland, EASi has 3,700 dedicated employees across North America, Europe and Asia. EASi is an Aerotek company, a leader in the recruiting and staffing industry. Aerotek is an operating company of Allegis Group Inc., a global leader in talent solutions. To learn more about EASi, visit EASi.com.

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

Keywords: Aerotek, Cape Coral , Senior Regulatory Affairs Specialist, Other , Naples, Florida

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Florida jobs by following @recnetFL on Twitter!

Cape Coral RSS job feeds