SAF Regulatory/Environmental Lead - 6740778_1-7970

This job was posted by : For more

information, please see: Volt is immediately hiring a Remote Regulatory Affairs Consultant with a well known industry leader in Maplewood, MN. In this Regulatory Affairs Consultant position, you will have the opportunity to act as the lead Regulatory Affairs on cross-functional teams for drug products within the Medical Surgical business.

As a Regulatory Affairs Consultant you will:

• Conduct global regulatory change assessments and coordinating

associated activities for assigned products.

• Support global regulatory strategies for changes related to

post-market changes.

• Demonstrate operational and strategic mindset that is

results-oriented with a strong bias towards executing with speed, agility, and quality

• Demonstrate excellent organizational, prioritization, oral and

written communication skills

• Provide regulatory review of technical reports and documents.
• Lead regulatory filings as needed for change projects (directly for

USA)

• Support risk management activities, vigilance reporting activities,

and other quality related initiatives with minimal oversight.

This is a full-time contingent opportunity

The ideal candidate will have:

• Bachelor\'s Degree in scientific discipline (e.g. Chemistry,

Chemical Engineering) or higher AND minimum five (5) years of experience in regulatory affairs in the drug (pharmaceutical), and medical device industry with experience working on combination medical devices.

Preferred skills:

• Direct experience authoring regulatory submissions/technical

documentation

• Direct experience authoring regulatory strategies and regulatory

change assessments

• Experience working with regulatory support for wound dressings

and/or surgical products

• Experience working and providing regulatory support for new product

development teams

• Experience developing regulatory strategies, label and claims review

and project management.

Pay Rate: \$76.00-93.00 per hour

*Pay range offered to a successful candidate will be based on several

factors, including the candidate\'s education, work experience, work location, specific job duties, certifications, etc.

Qualified candidates should APPLY NOW for immediate consideration!

Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

Benefits: Volt offers benefits (based on eligibility) that include

the following: health, dental, vision, term life, short term disability, AD&D, 401(k), Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

Volt is an Equal Opportunity Employer and prohibits any kind of

unlawful discrimination and harassment. Volt is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please email [email protected] or call (866) -898-0005. Please indicate the specifics of the assistance needed.

Volt does not discriminate against applicants based on citizenship

status, immigration status, or national origin, in accordance with 8 U.S.C. 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

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