surgery markets. PMT Corporation provides future opportunities in sales, marketing and management. POSITION The Quality and Regulatory Department support the registration and compliance of PMT’s products in the US and for over 100 distributors worldwide, selling specific PMT products.
The Regulatory Affairs Specialist will focus on assisting PMT maintain product compliance with FDA/MDSAP, ISO, and MDD/MDR requirements. This is a salary position and is an in-office position where the candidate will be working at PMT headquarters in Chanhassen, MN 8:00am – 4:30pm, M-F. DUTIES backss regulatory requirements and develop procedures and strategies for maintaining compliance. Maintenance of
FDA/MDSAP, ISO, and MDD/MDR compliance. Work with Engineering and Quality departments in product development to ensure compliance throughout design and manufacturing processes.
Review Engineering Change Orders relating to design, engineering, or manufacturing. Work directly with internal auditors and quality managers on compliance related matters. Maintain good relationship and interact directly with external auditors and regulatory agencies at the reviewer level. Interact with regulatory departments for international distributors to assist in registrations and license and certificate renewals. Provide support and leadership on development projects and regulatory issues to ensure timely
submissions for market clearance. Prepare US and international submissions for new products or products with changes in a timely manner.
REQUIREMENTS Bachelor’s degree in science, regulatory affairs, engineering, or other related field. Strong attention to detail. Minimum 2 years’ experience in regulatory affairs in health sciences, preferably medical devices. Regulatory Submission experience with 510Ks, notified bodies, or international MOH agencies. Knowledge of regulatory process for US and EU, experience in other countries a plus. Strong work ethic able to consistently exceed expectations. Excellent communication and time management skills. Proficient in Microsoft Office Suite and Adobe. PMT is an Equal Opportunity Employment
- Stock #399842 - Bunk house model!
Travel trailer with a sleep capacity of 11! Ready to hit the road!
If you are in the market for a travel trailer, look no further than this 2021 Aspen Trail 2910 BH, priced right at $31,700. Non-smoking and pet-free. This Travel Trailer is located in Titus, Alabama and is in good condition.
- Stock #397589 - Like new Durango Half-Ton 286BHD!
One owner! Beautiful, spacious interior loaded with amenities! Ready for your next adventure!
The 2022 Durango Half-Ton 286BHD by KZ is a travel trailer designed for families and adventurers alike. With a focus on comfort, convenience, and functionality, this RV offers a versatile and enjoyable
The seller's representative has not seen this unit in person but scheduling a photo session soon. Stay tuned!
- Stock #401393 - Well maintained 2018 Forest River Rockwood 8301WS fifth wheel!
Ready to hit the road!
If you are in the market for a fifth wheel, look no further than this 2018 Rockwood 8301WS, priced right at $35,000. Non-smoking and pet-free. This Fifth Wheel is located in Phoenix, Arizona and is in good condition.
- Stock #400301 - Two awnings!
Plenty of storage! In great condition!
If you are in the market for a travel trailer, look no further than this 2017 Forest River Spartan 1434X, priced right at $50,000. This Travel Trailer is located in Green Valley, Arizona and is in good condition.
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Splendide washer & dryer! Onan generator!
This fifth-wheel trailer is manufactured by Jayco, known for producing high-quality recreational vehicles. The North Point 385THWS is designed to provide comfort and convenience for travelers seeking adventure on the road. Here
This unit is in good condition and all features work as designed according to the seller. If you are looking for a nice fifth wheel that has been well maintained and at a good price, schedule a showing today before it's gone.