Regulatory Affairs Specialist II

At Benchmark , we are driven by our purpose: to innovate for a healthier, safer, and better-connected world to create a brighter future. When you join us, you become part of a team passionate about making a meaningful impact across various sectors, including commercial aerospace, defense, advanced computing, next-generation communications, complex industrials, medical, and semiconductor capital equipment. We prioritize career growth, fostering a culture that ensures you reach your full potential. At Benchmark, your work is purpose-driven, enabling you to create a positive impact on the world and make your career truly meaningful. You'll be part of a collaborative and inclusive team that values your ideas and contributions.

Summary:
Regulatory Affairs Specialist performs reviews and audits of certification related documentation, ensuring compliance to all quality management standards, governmental rules, regulations and requirements for the contract manufacturing of products. Fosters divisional teamwork within a continuous improvement environment. Provides regulatory and quality systems support for manufacturing, operations and product development.

Responsibilities:

• Working knowledge of ISO 13485,
• Working knowledge of 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
• Monitors and report on key quality and performance indicators as related to regulatory system conformance
• Keeps 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
• Participates with customer teams, supporting 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
• 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
• • Demonstrate the ability to interpret and communicate moderately complicated quality system regulations
• Work with larger customers and more complex regulatory requirements and audits
• Recommend new or revised metrics to better qualify/quantify performance
• May lead continuous improvement efforts in functional or cross-functional teams
• May give direction and leadership to lower level employees
• Provide regulatory product support including review of change plans, CAPAs and documentation for changes requiring regulatory body approval, and post-market requirements.
• Lead CAPAs and support the CAPA management process through activities such as verification of effectiveness.
• Maintain internal audit requirements checklists, ensuring that applicable standards are utilized and updated as revisions are introduced.
• Conduct internal audits and support external audits and inspections.
• Work with cross functional teams to implement quality management system improvements
• • Act as a regulatory representative on product development teams and communicate regulatory requirements and impact of regulations to the development team.

Education: 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

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

Geographical Location: Minnesota:Winona

Physical Location: Winona, MN - Central (4155)

Shift: Shift 1

Work Schedule: M-F 0800-1700

Full Time

In our innovative environment, you'll work with cutting-edge technology, leading the way in engineering design and delivering world-class manufacturing services for products that make a real difference in the lives of others. At Benchmark, your career is more than just a job. It's an opportunity to be part of something bigger, where your work matters and helps shape a brighter future for everyone. Together, we will achieve extraordinary things.

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.

Benefits and Other Compensation: 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 View email address on click.appcast.io.

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.

Benchmark is an equal opportunity employer. We are bringing together a dynamic workforce with unique talents, life experiences, cultures, and perspectives to promote an innovative, collaborative, and creative place to work. If you need assistance or an accommodation due to a disability, please email us at View email address on click.appcast.io.