Regulatory Affairs Specialist II

Benchmark · Winona, MN · 3 wk ago

Legal$81k–$99k/yrFull-time

Responsibilities

Working knowledge of ISO 13485, FDA QSR/QMSR (21CFR part 820)
Medical Device Experience
Auditing internal and external
Reviewing and approving of documentation
Participates and contributes to regulatory departmental management meetings and goal accomplishment
Serves as customer team liaison for customer audits/questions related to specification requirements
Works directly with customers, as required, in support of the customer teams, interfacing on change notification activities, clarification of status and other such communication
Maintains updated on latest and future regulatory requirements and quality management standards, incorporating changes and additions into review and audit practices
Actively participates in continuous improvement initiatives
Reviews applicable procedures and work instructions/forms supporting quality system regulation processes for compliance to requirements
Supports NPI and ongoing production needs related to regulatory requirements
Other information: Ability to interpret, understand, and apply regulatory requirements and quality management standards as applicable to assigned customers, projects and/or products
Capable of performing timely and accurate review of MRR and MRR waiver submittal
Capable of performing timely and accurate review of validations such as IQ, OQ and PQ documentation
Demonstrate effective customer interface skills
Demonstrate confidentiality
Ability to work with supervision and guidance
Demonstrate strong and effective interpersonal skills
Demonstrate strong presentation and communication skills, both written and verbal, with internal and external customers
Demonstrate strong problem solving and decision making skills
Demonstrate strong organizational skills
Knowledge of ISO quality management standards and other standards related to business sectors that support customers’ needs/products; electronic device contract manufacturing preferred

Requirements

4 year College Degree or equivalent combination of education and experience as approved by executive management
5+ years of regulatory experience with moderate to complex key customers

Qualifications

Ability to interpret, understand, and apply regulatory requirements and quality management standards as applicable to assigned customers, projects and/or products
Capable of performing timely and accurate review of MRR and MRR waiver submittal
Capable of performing timely and accurate review of validations such as IQ, OQ and PQ documentation
Demonstrate effective customer interface skills
Demonstrate confidentiality
Ability to work with supervision and guidance
Demonstrate strong and effective interpersonal skills
Demonstrate strong presentation and communication skills, both written and verbal, with internal and external customers
Demonstrate strong problem solving and decision making skills
Demonstrate strong organizational skills
Knowledge of ISO quality management standards and other standards related to business sectors that support customers’ needs/products; electronic device contract manufacturing preferred

Skills

Ability to interpret, understand, and apply regulatory requirements and quality management standards as applicable to assigned customers, projects and/or products
Capable of performing timely and accurate review of MRR and MRR waiver submittal
Capable of performing timely and accurate review of validations such as IQ, OQ and PQ documentation
Demonstrate effective customer interface skills
Demonstrate confidentiality
Ability to work with supervision and guidance
Demonstrate strong and effective interpersonal skills
Demonstrate strong presentation and communication skills, both written and verbal, with internal and external customers
Demonstrate strong problem solving and decision making skills
Demonstrate strong organizational skills
Knowledge of ISO quality management standards and other standards related to business sectors that support customers’ needs/products; electronic device contract manufacturing preferred

Benefits

Compensation Range: $81,154.00 to $99,453.00 USD.

Many factors are considered in compensation decisions, including but not limited to skills, certifications, licensures, experience, training, incumbent data, and other business needs.

Benchmark provides a comprehensive benefits package, including a Bonus Plan, 401(k), Paid Time Off, and Health, Dental, and Vision Insurance, all based on scheduled hours.

Benchmark complies with applicable state and local employee leave laws.

Application Deadline: This job posting will remain open until filled.

Additional Notices: Benchmark adheres to applicable state and local laws regarding employee leave benefits. This includes, but is not limited to, providing time off pursuant to the Colorado Healthy Families and Workplaces Act, in accordance with its plans and policies.

Candidates applying for remote work based in Washington state, may obtain PTO eligibility for this position by emailing careers@bench.com .

Export Control: This job position may include access to controlled information or technology covered under applicable U.S. export control laws. As such, employment for this job position may be contingent on either verification that an applicant falls under the definition of a “U.S. Person” (which includes U.S. citizens, U.S. lawful permanent residents, and those granted U.S. asylum or refugee status) or on the Company timely obtaining any necessary export license required under federal laws.

The Company evaluates such export license situations on a case-by-case basis and may decline to proceed with a job applicant in its sole discretion since export license applications can take many weeks to be processed.