Sr. Regulatory and Clinical Affairs Specialist

Industry

Science and Research

Advert ID

FOX_BBBH48015

Location

Plymouth

Job Type

Permanent

Hours

Full-Time

Salary Range

USD107000-129000 per year

No. of Openings

1

Branch Information

Minnesota Engineering - (USA) 3600 Minnesota Drive Suite 850 MN Edina , MN 55435

ContactNumber

612-630-1200

Job Description

Sr. Regulatory & Clinical Affairs Specialist | Direct Hire | $107-$129k Salary | Plymouth, MN



This position is responsible for preparing and coordinating regulatory submissions in accordance with policies and procedures on a world-wide basis. This position works closely with product development teams to develop and provide timely and accurate regulatory requirements, submission strategies and guidance for new products and product modifications. This position works closely with regulatory authorities to assure that products comply with regulatory requirements and are approved in a timely manner; this position also liaisons with third-party, external clinical experts for strategic clinical feedback.



Essential Job Functions:







* Serve as the senior most shared regulatory resource subject matter expert across Nonin's product portfolios.

* Prepare and maintain U.S. regulatory submissions for product approval and/or marketing clearance.

* Prepare and maintain international product submissions to meet registration, licensing, certification and approval requirements.

* Monitor international regulatory changes and communicate appropriate information and actions throughout the company.

* Identify, understand and apply worldwide regulatory laws and regulations to our business.

* Evaluate changes to product design and labeling and maintain a documented regulatory history of compliance for the life of our products.

* Establish /maintain policies and procedures that detail the conduct of regulatory activities at Nonin Medical Inc.

* Assist in the development of the regulatory budget.

* Meet defined goals and objectives through own initiatives, activities and available resources with minimum of supervision.

* Develop global regulatory strategies for Nonin product(s), product families, product claims, and competitive positions.

* Develop and communicate regulatory requirements to product development teams and work closely with the team(s) to assure compliance with and understanding of all regulatory strategies.

* Perform reviews of labels, labeling, literature, and web site for accuracy, consistency, and regulatory compliance.

* Initiate and/or participate in the review and development of new legislation and/or regulations and assist in the preparation of comments for submission into the promulgation process.

* Provide regulatory support for product complaints and worldwide adverse event reporting requirements.

* Serve as the liaison between Nonin and third-party CROs or MROs, as needed.

* Mentorship and coaching of junior team members.



Minimum Qualifications:



Required Education & Experience:







* Bachelor's in engineering, biological sciences, medical or related and minimum 5-10 years' experience in preparing and executing regulatory submissions on a world-wide basis or equivalent combination of education and experience.



Preferred Qualifications:







* Experience in and knowledge of international registration, licensing and regulatory affairs.