Sr Regulatory Affairs Spec
BioCT Innovation Commons, California, MO, United States
Senior Regulatory Affairs Specialist (Sr. RAS) – Medtronic
Lead regulatory activities for the Basic Energy and Access and Instrument product portfolio. Work collaboratively to plan, develop and submit regulatory documents such as 510(k) applications, CE technical files, and change notices for US and EU markets. Translate regulatory requirements into actionable project or product requirements and partner with engineering, quality, clinical, and marketing teams to ensure accurate, on‑schedule regulatory deliveries.
Responsibilities
Provide strategic and technical regulatory guidance for design and manufacturing sustaining activities covering domestic and international requirements.
Prepare 510(k) submissions, letter to file, change notices and updates to technical documents for US and EU markets.
Interact and negotiate with regulatory authorities during product development and review processes.
Collaborate with engineering, quality, clinical, marketing, and other departments to fulfill regulatory responsibilities.
Review and approve promotional and advertising materials for compliance.
Stay up to date on domestic and international regulatory requirements, guidelines, and standards.
Participate in internal and external audits and inspections as required.
Maintain regulatory documentation to ensure compliance.
Coordinate and prepare document packages for regulatory submissions, audits, and inspections.
Manage multiple projects, prioritize daily tasks, and ensure project deadlines are met.
Interact directly with regulatory agencies on defined matters as needed.
Contribute to continuous improvement initiatives and process optimization within Regulatory Affairs.
Perform additional duties as assigned.
Minimum Requirements
Bachelor’s degree with 4+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry OR a master’s degree with 2+ years of regulatory affairs experience in the same industries.
For Baccalaureate degrees earned outside of the United States, the degree must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A).
Nice to Have
Knowledge of FDA and EU MDR requirements.
Experience working with all classifications of products in the U.S. and/or EU.
Design dossier and/or technical documentation experience.
Technical writing skills.
International medical device regulatory submission/approval experience, including FDA and EU MDR.
Product labeling requirements and standards knowledge.
Practical knowledge of project management.
Systems knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems.
Physical Job Requirements
The job requires regular mobility, computer interaction, and communication with peers. Reasonable accommodations may be made for individuals with disabilities. Office roles also require independent mobility.
U.S. Work Authorization & Sponsorship
U.S. work authorization sponsorship is offered exclusively for Principal‑level roles and above. Positions below Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Benefits & Compensation
Salary range (U.S., excluding Puerto Rico): $92,000 – $138,000 per year, subject to experience and market conditions. Eligible for the Medtronic Incentive Plan (MIP).
Health, dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long‑term disability leave
Dependent daycare spending account
Tuition assistance / reimbursement
Simple Steps global well‑being program
Incentive plans
401(k) plan with employer contribution and match
Short‑term disability coverage
Paid time off and paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non‑qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to VPs and above, or subject to IRS earning minimums)
Equal Employment Opportunity
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
Additional Legal Information
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
#J-18808-Ljbffr
Lead regulatory activities for the Basic Energy and Access and Instrument product portfolio. Work collaboratively to plan, develop and submit regulatory documents such as 510(k) applications, CE technical files, and change notices for US and EU markets. Translate regulatory requirements into actionable project or product requirements and partner with engineering, quality, clinical, and marketing teams to ensure accurate, on‑schedule regulatory deliveries.
Responsibilities
Provide strategic and technical regulatory guidance for design and manufacturing sustaining activities covering domestic and international requirements.
Prepare 510(k) submissions, letter to file, change notices and updates to technical documents for US and EU markets.
Interact and negotiate with regulatory authorities during product development and review processes.
Collaborate with engineering, quality, clinical, marketing, and other departments to fulfill regulatory responsibilities.
Review and approve promotional and advertising materials for compliance.
Stay up to date on domestic and international regulatory requirements, guidelines, and standards.
Participate in internal and external audits and inspections as required.
Maintain regulatory documentation to ensure compliance.
Coordinate and prepare document packages for regulatory submissions, audits, and inspections.
Manage multiple projects, prioritize daily tasks, and ensure project deadlines are met.
Interact directly with regulatory agencies on defined matters as needed.
Contribute to continuous improvement initiatives and process optimization within Regulatory Affairs.
Perform additional duties as assigned.
Minimum Requirements
Bachelor’s degree with 4+ years of regulatory affairs experience in the medical device, biotech or pharmaceutical industry OR a master’s degree with 2+ years of regulatory affairs experience in the same industries.
For Baccalaureate degrees earned outside of the United States, the degree must satisfy 8 C.F.R. § 214.2(h)(4)(iii)(A).
Nice to Have
Knowledge of FDA and EU MDR requirements.
Experience working with all classifications of products in the U.S. and/or EU.
Design dossier and/or technical documentation experience.
Technical writing skills.
International medical device regulatory submission/approval experience, including FDA and EU MDR.
Product labeling requirements and standards knowledge.
Practical knowledge of project management.
Systems knowledge such as RA systems, Agile, SharePoint, or Quality Management Systems.
Physical Job Requirements
The job requires regular mobility, computer interaction, and communication with peers. Reasonable accommodations may be made for individuals with disabilities. Office roles also require independent mobility.
U.S. Work Authorization & Sponsorship
U.S. work authorization sponsorship is offered exclusively for Principal‑level roles and above. Positions below Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Benefits & Compensation
Salary range (U.S., excluding Puerto Rico): $92,000 – $138,000 per year, subject to experience and market conditions. Eligible for the Medtronic Incentive Plan (MIP).
Health, dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long‑term disability leave
Dependent daycare spending account
Tuition assistance / reimbursement
Simple Steps global well‑being program
Incentive plans
401(k) plan with employer contribution and match
Short‑term disability coverage
Paid time off and paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non‑qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to VPs and above, or subject to IRS earning minimums)
Equal Employment Opportunity
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
Additional Legal Information
If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
#J-18808-Ljbffr