Sr. Regulatory Affairs Specialist
Compensation: $112,220.00 - $140,040.00 /year *
Employment Type: Full-Time
Industry: Advertising/Marketing/Public Relations
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Kelly Services Outsourcing & Consulting Group (OCG) has an opening for a Sr. Regulatory Affairs Specialist. This assignment is for 2+ years, comes with benefits and is 100% office based in Cincinnati, OH. The Regulatory Affairs Specialist provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support modified product launches. Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. The RA Associate helps to define data and information needed for regulatory approvals in conjunction with cross-functional product teams. The role assists in the development of best practices for Regulatory Affairs processes. Regulatory Affairs experience in medical device and experience with EMEA is required. DUTIES & RESPONSIBILITIES:
- Ensures compliance with regulatory agency regulations and interpretations.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Provides solutions to a variety of problems of moderate scope and complexity.
- Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates
- Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance
- Provides regulatory guidance to product development teams and responds to product information requests
- Assists in the development of best practices for Regulatory Affairs processes
- Represents Regulatory Affairs on cross-functional project teams
Functional and Technical Competencies:
- Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products (for example, provides Regulatory input into product recall strategies).
- Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
- Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions.
- Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.
- Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels
- Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with local and/or regional regulatory agencies, industry groups, standards committees, political/government agencies, to influence external stakeholders and promote Regulatory perspectives
- Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions
- Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances
EDUCATION & EXPERIENCE REQUIREMENTS:
- Bachelor degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration
- 6-8 years of medical device regulatory affairs experience required
- RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable
- Experience with, or exposure to, foreign regulatory submissions (EMA) and European expertise (EUMDD) required
- Experience supporting tech files and Dossiers
- Must be actively working within the current regulations and have knowledge of the new regulation changes
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration! This position comes with enhanced benefits which include:
- 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*
- Paid holidays
- Paid sick days and vacation days*
Perks of being a Kelly employee:
- Weekly electronic pay
- Access to more than 3,000 online training courses though Kelly Learning center
- Online application system
- Never an applicant fee
benefits to be received upon meeting eligibility requirements Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.
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Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.Job Requirements:* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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