HCS360 has been engaged to find a Regulatory Affairs Leader for a smaller division of a large international company located in the Pittsburgh area. They offer excellent career-pathing and an opportunity to work in all aspects of Regulatory Affairs. They will provide generous relocation, and all interviewing expenses.
Please see below to learn more about the Pittsburgh area:
Forbes #7 on 2010 List of Great place to raise a family: http://www.post-gazette.com/pg/10159/1064054-100.stm
Forbes #1 on 2010 List of TOP housing market based on 3 key measures: http://www.msnbc.msn.com/id/35591286/ns/business-forbescom/
2010 Most Livable US city: http://www.forbes.com/2010/04/29/cities-livable-pittsburgh-lifestyle-real-estate-top-ten-jobs-crime-income.html
As the Regulatory Leader of this division you will provide international regulatory leadership with the challenge to balance strategic operational goals with the day-to-day operations ensuring full regulatory compliance divison wide.
As part of the responsibilities, you will be:
- Preparing regulatory submissions (510K, PMA) to secrure FDA market clearance
- Participating in early stages of NPD ensuring alignment with regulatory bodies and an effective path to market
- Preparing regulatory submissions for Asia/Pacific and the Americas
- Ensuring compliance wth EU MDD
- Providing leadership/training for approved regulatory product labeling/marketing
To be considered for this role, you must have:
- Bachelor's degree in a science or other (preferably engineering)
- 10+ years in the Medical Device industry
- 5+ years experience in developing and leading regulatory submissions with international exposure
- Strong working knowledge of QSRs, including Design Controls
- Experience with ISO9001, ISO 13485, CE marking requirements, and MDD
- Excellent written, listening, and verbal communication skills
Please send your resume to Beth Mulligan at bmulligan@hcs360.com for more details.