Top 962 Regulatory affairs lead Jobs in California

International Regulatory Affairs Lead (Medical Devices)
Apple —Cupertino, CA
- $218,300 - $363,700 a year
- Bachelor of Science
- Presentation skills
- Bachelor's degree
- Employee stock purchase plan
- Health insurance
FDA Submissions Specialist
Confidential Healthcare Company —Los Angeles, CA
- $30 - $45 an hour
- Full-time
- Hybrid work
- 5 years
- Writing skills
- Doctor of Philosophy
- Health insurance
- Dental insurance
Quick Apply
Compliance Investigator II
Partnership HealthPlan of California —Fairfield, CA
- $96,970.04 - $121,212.56 a year
- Full-time
- Microsoft Excel
- HIPAA
- Office
Director of Safety & Risk Management
Confidential —North Hills, CA
- $90,000 - $120,000 a year
- Full-time
- Background check
- HIPAA
- Office
- Paid jury duty
- Health savings account
Quick Apply
6d
Manager of Vendor Oversight
Partnership HealthPlan of California —Fairfield, CA
- $122,667.11 - $159,467.24 a year
- Full-time
- 5 years
- Writing skills
- Research
Sr. Regulatory Affairs Specialist
Prismatik Dentalcraft —Irvine, CA
- $86,000 - $120,000 a year
- Full-time
- Microsoft Outlook
- 5 years
- Research
- Health insurance
- Dental insurance
Quick Apply
Head of Manufacturing Operations
Gallant —San Diego, CA
- From $145,000 a year
- Weekends as needed
- Background check
- Mentoring
- US work authorization
- Health insurance
- Dental insurance
Quick Apply
Vice President Medical Affairs
Precise Behavioral INC. —California
- $300,000 - $350,000 a year
- Full-time
- Remote
- Medicine
- Psychiatry
- Outpatient experience
- Health insurance
- Dental insurance
Quick Apply
Head of Quality
Gallant —San Diego, CA
- From $150,000 a year
- Weekends as needed
- Background check
- Master's degree
- 8 years
- Health insurance
- Dental insurance
Quick Apply
Consultant - Product Quality & Safety - Life Sciences & Healthcare
Deloitte —Los Angeles, CA
- $88,700 - $170,900 a year
- Full-time
- Up to 50% travel
- Bachelor's degree
- Product management
Consultant - Product Quality & Safety - Life Sciences & Healthcare
Deloitte —San Francisco, CA
- $88,700 - $170,900 a year
- Full-time
- Up to 50% travel
- Bachelor's degree
- Product management
Consultant - Product Quality & Safety - Life Sciences & Healthcare
Deloitte —Costa Mesa, CA
- $88,700 - $170,900 a year
- Full-time
- Up to 50% travel
- Bachelor's degree
- Product management
Executive Director
Brookdale Senior Living Inc. —Scotts Valley, CA
- $139,580 - $177,810 a year
- Nights as needed
- 5 years
- Writing skills
- Ability to lift 50 pounds
- Health savings account
- Paid holidays
Quick Apply
11d
Dialysis Facility Administrator
U.S. Renal Care —Chula Vista, CA
- $110,947 - $166,421 a year
- Full-time
- Nursing
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
Antitrust Attorney
Everforth —Emeryville, CA
- Full-time
- 5 years
- Writing skills
- Analysis skills
Quick Apply
12d
Director of Continued Medical Education
California Medical Association —Sacramento, CA
- $130,000 - $150,000 a year
- Full-time
- Public speaking
- Office
- Master's degree
- Health savings account
- Health insurance
Quick Apply
QC Microbiology Manager
Yoh, A Day & Zimmermann Company —Sacramento, CA
- $120,000 - $135,000 a year
- 3 years
- Master's degree
- Bachelor's degree
- Health savings account
- Disability insurance
Quick Apply
Pharmacovigilance Specialist
Amphastar Pharmaceuticals Inc. —Rancho Cucamonga, CA
- $110,000 - $140,000 a year
- Full-time
- Nursing
- Medicine
- Bachelor's degree
- Health savings account
- Health insurance
Quick Apply
3d
Western Territory Sales Manager - Medical Device
StarrTrax —San Francisco, CA
- $110,000 - $130,000 a year
- Full-time
- Management
- Up to 50% travel
- English
- Health insurance
- Dental insurance
Quick Apply
Clinical Medical Writer Consultant
Kaztronix —San Diego, CA
- Contract
- Remote
- 8 years
- Bachelor's degree
- Continuous improvement
Quick Apply
5d

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International Regulatory Affairs Lead (Medical Devices)

Apple -
Cupertino, CA

Apply Now

Job Details

$218,300 - $363,700 a year

Benefits

Employee stock purchase plan
Health insurance
Dental insurance
RSU
Retirement plan

Qualifications

Managing medical device teams
Program management
Clinical research
ISO standards
Global team management
Government relations (public relations strategies)
Regulatory submission editing and review
Biomedical regulatory compliance
Communication with regulatory authorities for clinical trials
Clinical quality assurance standards
International corporation experience
General management

Full Job Description

The Health group is looking for an International Regulatory Affairs Lead to head a team responsible for international expansion of Apple Health’s regulated medical device features. If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient organization who works closely together to build relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands across the globe.

Description

You will be the primary leadership team member on the Health Regulatory Affairs team representing the team on a diverse array of initiatives and new product development programs, with the goal of marketing new technologies in all of Apple’s international geographies. You will develop a variety of solutions to regulatory challenges and will exercise independent judgment in settling and communicating appropriate regulatory/quality strategy, actions and requirements, while overseeing a team of global regulatory experts across all geographies. This role will involve leading assessments of regulatory impact for new and modified wellness, Class I, II and III products, including identification of assumptions/risks/mitigations to develop and execute clear regulatory plans across the globe. In this leadership role, you will also:

Represent the Health Regulatory Affairs team in Executive meetings and reviews for topics representing our international expansion work.

Identify regulatory trends and opportunities that impact the strategic direction of Apple Health, and establish / implement plans that ensure sustained growth of business in region.

Build strong relationships with external stakeholders, including regulators and trade groups, across key global markets

Partner with cross-functional partners including Legal, Government Affairs, Policy, Quality and other external stakeholders

Set frameworks for technical writing, including distilling complex information into geo-specific filings, submissions, slides and other communication formats

Execute complex gap analyses for products/ programs against global regulations, standards and guidance in order to drive RA/QA strategy for international expansion programs

Preferred Qualifications

M.S./ PhD / post-secondary education preferred

Demonstrable background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.

Proven competence in determination of appropriate global regulatory requirements for new products or product changes.

Partnering with and across a broad swath of other Apple teams to set regulatory / quality strategy and “look around corners” to anticipate business impact

Strong organizational and management skills

Excellent communication skills, both verbal and written

Comfortable with presenting assessments and information to broad, multi-disciplinary teams

Minimum Qualifications

B.S. degree or equivalent in a life science, legal or business discipline

10+ years of medical device experience in a regulatory and/ or quality executive role, with at least 5+ years focused in leading and overseeing international programs

Proven track record in overseeing a large scope of international regulatory affairs matters including regulatory approvals, submissions, launch strategy

Experience leading global team of regulatory professionals, including establishing organizational objectives and proven success delivering as a team

Significant experience in crafting strategy interactions with regulatory health authorities in the US and abroad

Demonstrable track record of receiving regulatory approvals for complex products - including software medical devices - globally, across US, EU, APAC, LATAM, ASEAN and other regions

Deep expertise in developing global product submissions including STED, CDST and other global templates

Strong working knowledge of US, EU, APAC, LATAM, ASEAN and other global regulations that affect Class I, II and III devices

Strong knowledge of clinical investigations, validations and GCP requirements in the US and abroad

Significant expertise in global quality standards, including ISO 13485, ISO 14155, and related technical product-specific standards

Ability to be onsite; this role is a hybrid, in-person position

Pay & Benefits

At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role. The base pay range for this role is between $218,300 and $363,700, and your base pay will depend on your skills, qualifications, experience, and location.

Apple employees also have the opportunity to become an Apple shareholder through participation in Apple's discretionary employee stock programs. Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple's Employee Stock Purchase Plan. You'll also receive benefits including: Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses - including tuition. Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. Learn more about Apple Benefits

Note: Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.

Apply Now

Refine Your Search

regulatory affairs lead jobs in california

International Regulatory Affairs Lead (Medical Devices)

FDA Submissions Specialist

Compliance Investigator II

Director of Safety & Risk Management

Manager of Vendor Oversight

Sr. Regulatory Affairs Specialist

Head of Manufacturing Operations

Vice President Medical Affairs

Head of Quality

Consultant - Product Quality & Safety - Life Sciences & Healthcare

Consultant - Product Quality & Safety - Life Sciences & Healthcare

Consultant - Product Quality & Safety - Life Sciences & Healthcare

Executive Director

Dialysis Facility Administrator

Antitrust Attorney

Director of Continued Medical Education

QC Microbiology Manager

Pharmacovigilance Specialist

Western Territory Sales Manager - Medical Device

Clinical Medical Writer Consultant

I want to receive the latest job alert for regulatory affairs lead in california

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