Starkey Hearing Technologies
Sr Regulatory Affairs Specialist I
Starkey Hearing Technologies, Eden Prairie, Minnesota, United States, 55344
Starkey is adding a Sr. Regulatory Affairs Specialist I on its Regulatory team. This position is primarily remote, but at times it will be required to be onsite at the global headquarters and other sites as needed. The Sr. Regulatory Affairs Specialist I position is responsible for supporting the Regulatory Affairs Department for all medical devices and hearing‑related products. This position will work with various departments across the organization with focus on new product development. The Sr. Regulatory Affairs Specialist is responsible for supporting activities that keeps Starkey current with changes to medical device regulation and for creating and maintaining the technical files for all medical devices and hearing related products. Starkey offers full benefits, 4 weeks PTO, 401K match.
Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known for our cutting‑edge hearing health innovations, industry‑leading research and development, and not being afraid to push the edge of what's possible. We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide.
Watch this video to see more of what sets Starkey apart.
https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6
Our Culture
An experienced team built around a culture of professional growth and knowledge-sharing
We celebrate innovation - finding creative ways to serve our customers better than anyone else
Global leader in the design, development and distribution of comprehensive hearing technologies
We serve with passion, purpose and excellence
Here's the bottom line - we work so people can hear!
Job Responsibilities
Market Access - Ensure market access of our products World‑Wide
Support assessments and completion of documentation for submission filings to comply with regulatory requirements
Support labeling compliance before product release
Support coordination of homologation device delivery, testing & registration within new markets
Help to compile, prepare, review and submit regulatory submission to authorities
Provide regulatory input to product lifecycle planning
Maintain records to comply with regulatory requirements
Support wireless requirements compliance throughout the product development process.
Risk Management
Participate in product risk management within product development (per project) and work with others to mitigate
Ensure product safety issues and product‑associated events are reported to regulatory agencies
Participate in risk‑benefit analysis for regulatory compliance
Manage global Regulatory threats, changes and opportunities
Support senior personnel in periodical scan of changes in standards, regulations, guidance and events in the areas of Medical Devices, Radio Devices, Noise Protection Devices, and Environmental.
Some participation in professional associations, industry/trade groups and appropriate standards organizations
Other duties/responsibilities as assigned
Job Requirements Education:
Four‑year degree in Engineering or Science.
Experience:
Minimum 8 years experience with a four‑year degree, or 5 years experience with MS, or 2 years with Ph.D.
Knowledge of GxPs (GCPs, GLPs, GMPs) required
Knowledge of ISO 13485, MDSAP, EU MDR, Health Canada, 21CFR820
Knowledge of Quality Management Systems required
Knowledge of World‑Wide regulatory requirements desired
Knowledge of Import/export requirements desired
Knowledge of product marking requirements (by market) desired
Competencies, Skills & Abilities
Strategic Planning and organizing
Written and verbal communication
Presentation skills
Communicate with internal stakeholders and regulatory authorities
Prepare applications and regulatory documentation
Review and assess regulatory submissions
Utilize electronic submission techniques
Critical thinking and problem solving
Good attention to detail
Systems analysis skills desired
Salary and Other Compensation The target rate for this position is between $88,550 to $126,000 per year. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.
Benefits: The following benefits for this position, subject to applicable eligibility requirements, include medical, dental and vision insurance, 401(k) retirement plan with company match, company‑paid life and short‑term disability insurance, long‑term disability insurance, employee assistance plan, hearing aid benefits, paid time off, paid holidays, paid floating holidays, paid volunteer service day, paid paternity and maternity leave and tuition reimbursement.
This position is eligible for a bonus based upon performance results. There is no guarantee of payout.
Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities.
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.
#J-18808-Ljbffr
Starkey is a world leader in the manufacturing and distribution of advanced hearing technologies. We are in the business of connecting people and changing lives. Our teams come to work each day focused on ensuring people everywhere have the products and services they need to hear better and live better. Founded in 1967 by Bill Austin, Starkey is known for our cutting‑edge hearing health innovations, industry‑leading research and development, and not being afraid to push the edge of what's possible. We are headquartered in Eden Prairie, Minnesota, have over 5,000 employees in 29 facilities across the globe, and do business in more than 100 markets worldwide.
Watch this video to see more of what sets Starkey apart.
https://youtu.be/9cUYwTlCepg?si=wkovx8_R_iINfrc6
Our Culture
An experienced team built around a culture of professional growth and knowledge-sharing
We celebrate innovation - finding creative ways to serve our customers better than anyone else
Global leader in the design, development and distribution of comprehensive hearing technologies
We serve with passion, purpose and excellence
Here's the bottom line - we work so people can hear!
Job Responsibilities
Market Access - Ensure market access of our products World‑Wide
Support assessments and completion of documentation for submission filings to comply with regulatory requirements
Support labeling compliance before product release
Support coordination of homologation device delivery, testing & registration within new markets
Help to compile, prepare, review and submit regulatory submission to authorities
Provide regulatory input to product lifecycle planning
Maintain records to comply with regulatory requirements
Support wireless requirements compliance throughout the product development process.
Risk Management
Participate in product risk management within product development (per project) and work with others to mitigate
Ensure product safety issues and product‑associated events are reported to regulatory agencies
Participate in risk‑benefit analysis for regulatory compliance
Manage global Regulatory threats, changes and opportunities
Support senior personnel in periodical scan of changes in standards, regulations, guidance and events in the areas of Medical Devices, Radio Devices, Noise Protection Devices, and Environmental.
Some participation in professional associations, industry/trade groups and appropriate standards organizations
Other duties/responsibilities as assigned
Job Requirements Education:
Four‑year degree in Engineering or Science.
Experience:
Minimum 8 years experience with a four‑year degree, or 5 years experience with MS, or 2 years with Ph.D.
Knowledge of GxPs (GCPs, GLPs, GMPs) required
Knowledge of ISO 13485, MDSAP, EU MDR, Health Canada, 21CFR820
Knowledge of Quality Management Systems required
Knowledge of World‑Wide regulatory requirements desired
Knowledge of Import/export requirements desired
Knowledge of product marking requirements (by market) desired
Competencies, Skills & Abilities
Strategic Planning and organizing
Written and verbal communication
Presentation skills
Communicate with internal stakeholders and regulatory authorities
Prepare applications and regulatory documentation
Review and assess regulatory submissions
Utilize electronic submission techniques
Critical thinking and problem solving
Good attention to detail
Systems analysis skills desired
Salary and Other Compensation The target rate for this position is between $88,550 to $126,000 per year. Factors which may affect starting pay within this range may include geography/market, skills, education, experience and other qualifications of the successful candidate.
Benefits: The following benefits for this position, subject to applicable eligibility requirements, include medical, dental and vision insurance, 401(k) retirement plan with company match, company‑paid life and short‑term disability insurance, long‑term disability insurance, employee assistance plan, hearing aid benefits, paid time off, paid holidays, paid floating holidays, paid volunteer service day, paid paternity and maternity leave and tuition reimbursement.
This position is eligible for a bonus based upon performance results. There is no guarantee of payout.
Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities.
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.
#J-18808-Ljbffr